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FOI Documents NADA 000-000 to 139-999

Listed with Abstracts from the Summaries

NADA 006-707 supplemental approval
Sponsor: Solvay Animal Health, Inc.
Generic Name: Oxytetracycline (from oxytetracycline quaternary salt) equivalent to oxytetracycline hydrochloride
Trade Name: Sulquin 6-50 Concentrate
Effect of Supplement: DESI finalization recognizing that Sulquin 6-50 Concentrate is, when used as directed, safe and effective for the labeled indications.
Date of Approval: June 2, 1997

NADA 008-622 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: oxytetracycline Soluble Powder
Trade Name: Terramycin Soluble Powder
Effect of Supplement: One supplemental application is a Category II change to bring the drug product into compliance with the National Academy of Science/National Research Council Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations. The other supplemental application is a Category II change providing for a tolerance of O.1 ppm in uncooked edible tissues in sheep.
Date of Approval: July 9, 2000

NADA 008-622 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Terramycin®, Terramycin -343®
Effect of Supplement: This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days.
Date of Approval: April 25, 2001

NADA 008-804 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline Type A Medicated Article
Trade Name: TM-50®, TM-100®, TM-50®D, and TM-100®D
Effect of Supplement: This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days.
Date of Approval: March 14, 1996

NADA 008-804 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline Type A Medicated Article
Trade Name: TM-50®, TM-100®, TM-50®D, and TM-100®D
Effect of Supplement: This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days.
Date of Approval: April 29, 2002

NADA 008-804 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: sodium sulfaquinoxaline liquid
Trade Name: TM-50®, TM-50®D, TM-100®, TM-100®D Type A Medicated Articles
Indications for use: For increased rate of weight gain and improved feed efficiency; reduction of liver abscesses; for prevention and treatment of the early stages of shipping fever complex; the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline.
Date of Approval: March 12, 2004

NADA 009-576 supplemental approval
Sponsor: Syntex Animal Health
Generic Name: estradiol benzoate and progesterone
Trade Name: Synovex ; S
Effect of Supplement: This supplement provides for reimplantation of Synovex ; S at approximately day 70 in steers fed in confinement for slaughter for additional improvement in rate of weight gain.
Date of Approval: August 19, 1994

NADA 009-576 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: estradiol benzoate and progesterone
Trade Name: Synovex ; C Synovex ; S
Effect of Supplement:This supplement provides for the implantation of Synovex C in steers fed in confinement for slaughter when used as part of a reimplant program where Synovex S is implanted at approximately day 70 after the initial implantation of Synovex C.
Date of Approval: July 14, 1998

NADA 010-005 supplemental approval
Sponsor: Fleming Laboratories, Inc.
Generic Name: Piperazine hydrochloride, dipiperazine sulfate
Trade Name: Wazine; Pig Wormer
Effect of Supplement: This supplemental application provides for implantation in steers fed in confinement for slaughter for increased rate of weight gain and the establishment of an ADI for trenbolone.
Date of Approval: March 23, 1999

NADA 011-315 supplemental approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name: NEOMIX ; 325 Soluble Powder and NEOMIX ; AG 325 Soluble Powder
Effect of Supplement:The effectiveness neomycin sulfate was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: March 4, 1992

NADA 011-315 supplemental approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name:Neomycin 325/Neomix Ag 325 Soluble Powder
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats
Date of Approval: April 3, 1996

NADA 011-315 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: neomycin sulfate
Trade Name: NEOMIX® 325 Soluble Powder; NEOMIX® AG 325 Soluble Powder
Effect of Supplement: Provides for the use of neomycin sulfate (NEOMIX325Soluble Powder/NEOMIX® AG 325 Soluable Powder) in growing turkeys for the control of mortality associted withEscherichia coli organisms sussceptible to neomycin sulfate.
Date of Approval: July 9, 1999

NADA 011-427 supplemental approval
Sponsor: Syntex, Inc.
Generic Name: Estradiol benzoate and testosterone propionate
Trade Name: Synovex-H Heifer Finishing Implants
Effect of Supplement: Supplemental application to provide for the deletion of the 60-day withdrawal period statement in the labeling for Synovex-H.
Date of Approval: July 9, 1999

NADA 012-123 supplemental approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: erythromycin
Trade Name: GALLIMYCIN (Erythromycin)INJECTION, 200 mg/mL
Effect of Supplement: One supplemental application is a Category II change in dosage which was initiated in order to bring the drug product into compliance with the National Academy of Science/National Research Council- Drug. Efficacy Study Implementation (NAS/NRC/DESI) recommendations.The other supplemental application is a Category II change in tolerance for drug residues from zero to 0.1 ppm for beef tissues.
Date of Approval: June 30, 1993

NADA 012-491 original approval
Sponsor: Elanco Animal Health, a Division of Eli Lily and Company
Generic Name:tylosin phosphate
Trade Name: Tylan; Type A medicated article, Tylan; 100 Type A medicated article, Tylan; 100 Cal Type A medicated article
Indications for use: SWINE: For the prevention and/or control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; For increased rate of weight gain and improved feed efficiency; For prevention of swine dysentery (vibrionic); For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; and For the treatment and control of swine dysentery (vibrionic) following initial medication of TYLAN; in drinking water.
Date of Approval: November 8, 1996

NADA 034-025 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: Lincomycin hydrochloride monohydrate
Trade Name: Lincocin ; Sterile Solution; Lincomix; Injectable
Effect of Supplement: This supplement provides for the new tolerances for lincomycin in swine and the establishment of ADI for total residues of lincomycin.
Date of Approval: August 25, 1998

NADA 034-254 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA ; 100/200 Premix and MGA ; 500 Liquid Premix
Effect of Supplement: This supplement provides for the removal of the requirement for a 48-hour drug withdrawal period prior to slaughter for heifers fed melengestrol acetate.
Date of Approval: June 29, 1994

NADA 034-254 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix
Effect of Supplement: This supplement provides for the use of melengestrol acetate (MGA) in heifers intended for breeding for suppression of estrus (heat).
Date of Approval: February 18, 1997

NADA 038-200 supplemental approval
Sponsor: Fermenta Animal Health Company
Generic Name: oxytetracycline hydrochloride
Trade Name: OXY WS (TM) Soluble Antibiotic; MEDAMYCIN ; Soluble Antibiotic
Effect of Supplement:The effectiveness oxytetracycline HCl soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: July 10, 1993

NADA 038-233 supplemental approval
Sponsor: Pitman-Moore, Inc.
Generic Name: zeranol
Trade Name: RALGRO
Effect of Supplement: This supplement provides for the deletion of the caution statement in the labeling against the use of RALGRO ; in heifer (suckling beef) calves intended for reproduction.
Date of Approval: March 30, 1994

NADA 038-233 supplemental approval
Sponsor: Schering-Plough Animal Health Corp
Generic Name: zeranol
Trade Name: RALGRO ; Magnum
Effect of Supplement: This supplement provides for the use of an ear implant containing 72 mg zeranol in steers fed in confinement for slaughter for improved feed efficiency.
Date of Approval: June 25, 1999

NADA 039-077 supplemental approval
Sponsor: Fermenta Animal Health Company
Generic Names: chlortetracyline (as hydrochloride), sulfathiazole, penicillin (as procaine penicillin)
Trade Name: CSP(TM) 250 and CSP(TM) 500
Effect of Supplement:The supplemental NADA provides for revised Type A medicated article, and Type B and C medicated feed labeling. CSP(TM) can be used from 10 pounds body weight up to 6 weeks post-weaning.
Date of Approval: December 11, 1995

NADA 039-402 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA ; 100/200 Premix and MGA ; 500 Liquid Premix
Effect of Supplement: This supplement provides for the removal of the requirement for a 48-hour drug withdrawal period prior to slaughter for heifers fed melengestrol acetate.
Date of Approval: June 29, 1994

NADA 039-402 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix
Effect of Supplement: This supplement provides for the use of melengestrol acetate (MGA) in heifers intended for breeding for suppression of estrus (heat).
Date of Approval: February 18, 1997

NADA 039-417 supplemental approval
Sponsor: Rhone-Poulenc, Inc.
Generic Name: decoquinate, Type A medicated article.
Trade Name: Deccox;
Effect of Supplement: This supplement extends to non-ruminating calves the claim for the prevention of coccidiosis.
Date of Approval: April 12, 1991

NADA 039-417 supplemental approval
Sponsor: Rhone Poulenc Inc.
Generic Name: decoquinate
Trade Name: Deccox
Effect of Supplement: This supplement adds a new species (young sheep) to the approved label.
Date of Approval: August 18, 1995

NADA 039-417 supplemental approval
Sponsor: Rhone Poulenc Inc.
Generic Name: decoquinate
Trade Name: Deccox
Effect of Supplement: This supplemental application provides for a revised range of concentrations for the use of decoquinate in cattle, sheep and goats.
Date of Approval: September 4, 2002

NADA 040-209 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name: sulfadimethoxine and ormetoprim Type A medicated article
Trade Name: Rofenaid; 40
Effect of Supplement: This supplemental application provides for the addition of a new species (chukar partridges).
Date of Approval: April 1, 1999

NADA 041-061 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: Carbadox Type A Medicated Article
Trade Name: Mecadox; 10
Effect of Supplement: Provides for the codificaiton of a revised tolerance for residues of carbadox in edible tissues.
Date of Approval: January 30, 1998

NADA 041-061 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Carbadox
Trade Name: Mecadox; 10 Type A Medicated Article
Effect of Supplement: Provides for the establishment of a 42 day slaughter withdrawal period for carbadox in swine tissues and a limitation against use in pregnant swine or swine intended for breeding purposes.
Date of Approval: October 5, 1998

NADA 042-841 supplemental approval
Sponsor: Fort Dodge Laboratories
Generic Name: kanamycin, pectin, bismuth subcarbonate, activated attapulgite (aluminum magnesium silicate)
Trade Name: Amforol ; Veterinary Oral Tablets
Effect of Supplement: This supplement provides for a revised formulation for Amforol ; Veterinary Oral Tablets without aminopentamide hydrogen sulfate. The following issues are addressed:
Date of Approval: February 21, 1991.

NADA 044-759 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Flavomycin
Effect of Supplement: 21 CFR 558.95 currently provides for the use of bambermycins in poultry and swine. This supplement provides for the use of bambermycins in cattle fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 21, 1993

NADA 046-592 supplemental approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate
Trade Name: BMD ;
Effect of Supplement: This supplement adds the claim for the control of clostridial enteritis caused by C. perfringens in suckling piglets born to sows medicated with BMD.
Date of Approval: April 29, 1991.

NADA 046-592 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD®
Effect of Supplement: This supplemental application provides for the addition of a class,replacement chickens, to be added to the previously approved product.
Date of Approval: June 22, 1998

NADA 046-666 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Procaine G Penicillin
Trade Name: Procaine G Penicillin 50% Type A Medicated Article
Effect of Supplement: This supplemental application provides for compliance with theconclusions of the National Academy of Science/National Research Council(NAS/NRC) evaluation of penicillin-containing Type A Medicated Articles.
Date of Approval: April 10, 1998

NADA 046-668 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Procaine G Penicillin
Trade Name: Procaine G Penicillin 50% Type A Medicated Article
Effect of Supplement: This supplemental application provides for compliance with theconclusions of the National Academy of Science/National Research Council(NAS/NRC) evaluation of penicillin-containing Type A MedicatedArticles.
Date of Approval: April 10, 1998

NADA 046-699 supplemental approval
Sponsor: ALPHARMA, Inc.
Generic Name: Chlortetracycline
Trade Name: ChlorMax™ 50, ChlorMax™65, ChlorMax™70 Type A Medicated Article;
Effect of Supplement: This supplemental application adds the claim for the control of porcine proliferative enteropathies associated with Lawsonia intracellularis susceptible to chloretetracycline.
Date of Approval: July 7, 2000

NADA 046-718 (Liquid MGA) original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate (MGA)
Trade Name: MGA;, Terramycin;
Indications for use:
For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduction of liver condemnation due to liver abscesses in heifers fed in confinement for slaughter.
Date of Approval:
May 6, 1998

046-719(Dry MGA) original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate (MGA)
Trade Name: MGA;, Terramycin;
Indfications of use:
For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduction of liver condemnation due to liver abscesses in heifers fed in confinement for slaughter.
Date of Approval:
May 6, 1998

NADA 048-271 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Dichlorvos
Trade Name: Task; Tabs
Effect of Supplement: This supplemental application provides for the use in kittens not less than three months of age, for the use in adult dogs, and the addition of the 50 and 100 mg tablet sizes. Also, the list of sponsors is amended to reflect the sponsor’s current zip code (64506-2002).
Date of Approval: March 4, 1999

NADA 048-480 supplemental approval
Sponsor: A D M Animal Health & Nutrition, Inc.
Generic Name:Chlortetracycline Pre-mix
Trade Name: CHLORATET 50
Effect of Supplement: The effect of this Category II supplement is to bring the drug product into compliance with the National Academy of Science/National Research Council/ Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996

NADA 048-761 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: chlortetracycline
Trade Name: Aureomycin Type A Medicated Article
Effect of Supplement:
The approval provides for use of Aureomycin Type A Medicated Article for the control and treatment of specific diseases in swine, cattle, chickens,turkeys, and sheep.
Date of Approval: February 16, 1996

NADA 048-761 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: chlortetracycline
Trade Name: Aureomycin
Effect of Supplement:
This supplemental approval provides for a supplemental cattle feed (Moorman's Special Range Minerals AU Type C Medicated Feed) to provide 0.5-2.0 mg CTC/lb bodyweight/day for the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, in grazing beef cattle (weighing over 700 lbs). The resultant supplemental feed containing chlortetracycline is offered free-choice continuously throughout the period in which the cattle are grazing pasture.
Date of Approval: July 9, 1996

NADA 048-761 supplemental approval
Sponsor: Hoffmann La-Roche Inc.
Generic Name: chlortetracycline
Trade Name: Aureomycin;
Effect of Supplement: Changes all withdraal times to zero (0) days when fed at certain doses.
Date of Approval: September 23, 1997

NADA 048-761 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name:Chlortetracycline Pre-mix
Trade Name: Aureomycin; Type A Medicated Article
Effect of Supplement: Deletion of limitations statement, "Do not feed to chickens producing eggs for human consumption" and establishment of a Tolerance for chlortetracycline in eggs.
Date of Approval: July 31, 1998

NADA 048-761 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name:Chlortetracycline
Trade Name: Aureomycin Type A Medicated Article
Effect of Supplement: Changes the withdrawal time from 24 hours to zero (0) day withdrawal when chlortetracycline is fed to chickens at 500 g/ton of feed for 5 days for reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline.
Date of Approval: October 26, 1998

NADA 048-761 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name:Chlortetracycline
Trade Name: AUREOMYCIN® 50, 90 or 100 GRANULAR
Effect of Supplement: Provides for top dressing AUREOMYCIN at the rate of 10 mg chlortetracycline (equivalent to chlortetracycline hydrochloride) per pound of bodyweight of Type C medicated feeds for cattle.
Date of Approval: January 24, 2002

NADA 048-761 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name:Chlortetracycline
Trade Name: AUREOMYCIN® 50, 90 or 100 GRANULAR
Effect of Supplement: This supplemental application adds the claim for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.
Date of Approval: November 15, 2001

NADA 049-287 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: Pfichlor Chlortetracycline Pre-mix
Trade Name: Type A Medicated Article
Effect of Supplement: Category II change.
Date of Approval: July 7, 1993

NADA 055-020 supplemental approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline bisulfate soluble powder concentrate
Trade Name: Aureomycin Soluble Powder Concentrate
Effect of Supplement: This supplement upgrades the status finding of the NAS/NRC from "probably effective" to "effetive" with respect to the claims regarding control and treatment of the specifically noted diseases for certain animals as stated above.
Date of Approval: April 6, 1995

NADA 055-099 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: amoxicillin trihydrate/clavulanate potassium
Trade Name: Clavamox; Tabs
Effect of Supplement: Provides for additional claim against canine periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.
Date of Approval: December 23, 1997

NADA 055-101 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: amoxicillin trihydrate/clavulanate potassium
Trade Name: Clavamox° Drops
Effect of Supplement: Adds claims for periodontal infections in dogs.
Date of Approval: December 23, 1997

NADA 065-010 supplemental approval
Sponsor: Norbrook Laboratories Limited
Trade Name: AQUA-CILLIN
Generic Name: sterile penicillin G procaine suspension, USP
Effect of Supplement: This supplement provides for the reduction of the milk withholding period from 72 hours (6 milkings) to 48 hours.
Date of Approval: July 16, 1992

NADA 065-071 supplemental approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline soluble powder
Trade Name: AUREOMYCIN Soluble Powder
Effect of Supplement:The effectiveness chlortetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: June 15, 1994

NADA 065-123 supplemental approval
Sponsor: Pfizer Inc.
Generic Name:tetracycline soluble powder
Trade Name: TETRACYCLINE SOLUBLE POWDER
Effect of Supplement:The effectiveness tetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: February 18, 1994

NADA 065-140 supplemental approval
Sponsor: Wade Jones Company
Generic Name: tetracycline soluble powder
Trade Name: TET-SOL 324
Effect of Supplement:The effectiveness tetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: September 15, 1993

NADA 065-252 supplemental approval
Sponsor: Veterinary Services, Inc.
Generic Name: Strep-SoL
Trade Name: streptomycin sulfate 25% solution
Effect of Supplement:1) The effectiveness streptomycin sulfate 25% solution was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary. 2) Change in tolerance
Date of Approval: September 5, 1993

NADA 065-256 supplemental approval
Sponsor: Feed Specialties Co.
Generic Name: chlortetracycline soluble powder
Trade Name: Chlortet-Soluble-O
Effect of Supplement:The effectiveness chlortetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval:
October 15, 1993

NADA 065-269 supplemental approval
Sponsor: American Cyanamid
Generic Name: tetracycline soluble powder
Trade Name: POLYOTIC
Effect of Supplement:The effectiveness tetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: April 29, 1993

NADA 065-440 supplemental approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline soluble powder concentrate
Trade Name: AUREOMYCIN Soluble Powder Concentrate
Effect of Supplement:The effectiveness chlortetracycline soluble powder concentrate was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: June 15, 1994

NADA 065-441 supplemental approval
Sponsor: American Cyanamid
Generic Name: tetracycline soluble powder concentrate
Trade Name: POLYOTIC
Effect of Supplement:The effectiveness tetracycline soluble powder concentrate was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: April 23, 1993


NADA 065-470 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD; Soluble
Effect of Supplement: This supplemental application provides for the addition of an additional species, growing quail, to the previously approved product.
Date of Approval: May 27, 1998

NADA 065-470 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD; Soluble
Effect of Supplement: This supplemental application provides for the addition of a new class, replacement chickens, to the previously approved product.
Date of Approval: February 2, 1999

NADA 065-480 supplemental approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline hydrochloride
Trade Name: Chlortetracycline Soluble Powder
Effect of Supplement: This supplemental application provides for a revised withdrawal period (from five to zero days) in swine.
Date of Approval: December 22, 1999

NADA 065-505 original approval
Sponsor: Anthony Products Co.
Generic Name: penicillin G procaine
Trade Name: Microcillin-AG ; ;
Indications for use: Microcillin-AG ; in aqueous suspension is intended for use in the treatment of the following diseases when due to penicillin susceptible organisms in cattle, sheep, swine, and horses. Cattle and Sheep: Microcillin-AG ; is indicated for the treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida. Swine: Microcillin-AG ; is indicated for the treatment of erysipelas caused by Erysipelothrix insidiosa. Horses: Microcillin-AG ; is indicated for the treatment of strangles caused by Streptococcus equi.
Date of Approval: January 29, 1993

NADA 065-506 original approval
Sponsor: Anthony Products Co.
Generic Name: penicillin G benzathine and penicillin G procaine.
Trade name: Combicillin ; or Combicillin-AG ;
Indications for use: The prescription product, Combicillin ; is indicated for use in beef cattle, in horses, and in dogs for bacterial infections due to the following microorganisms that are susceptible to the serum levels of penicillin common to this particular dosage form: Pneumonia (shipping fever complex) caused by Streptococcus spp., Corynebacterium pyogenes, Staphylococcus aureus; Upper respiratory infections such as rhinitis or pharyngitis caused by Corynebacterium pyogenes; Equine strangles caused by Streptococcus equi; Blackleg caused by Clostridium chauvoei.
Date of Approval: November 8, 1993

NADA 092-286 supplemental approval
Sponsor:Pfizer, Inc.
Generic Name:Chlortetracycline Pre-mix
Trade Name:CLCT 10, 20, 30, 50, 70
Effect of Supplement: The effect of this Category II supplement is to bring the drug product into compliance with the National Academy of Science/National Research Council/ Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996

NADA 092-287 supplemental approval
Sponsor:Pfizer Inc
Generic Name:chlortetracycline pre-mix milk replacer
Trade Name:CLCT 50 MR & 100 MR
Effect of Supplement: The effect of this Category II supplement is to bring the drug product into compliance with the National Academy of Science/National Research Council/ Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996

NADA 092-444 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: morantel tartrate
Trade name: Rumatel ; 88
Effect of Supplement: This supplement provides for an additional claim for use of this Type A medicated article to produce Type C medicated feed for Goats.
Date of Approval: March 17, 1994

NADA 094-170 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Phenylbutazone Tablets
Trade name: Phenylbutazone Tablets USP 200 mg
Effect of Supplement: To provide for a 200 mg phenylbutazone tablet.
Date of Approval: January 12, 2001

NADA 095-143 original approval
Sponsor: Pfizer Inc.
Generic Name:oxytetracycline dyhydrate pre-mix
Trade Name: OXTC 10, 30, 50, 50-S, 100, 100-S, 100MR
Indications for use: For the control and treatment of specific diseases susceptible to oxytetracycline dihyrate pre-mix in swine, calves, cattle, chickens, turkeys, sheep, and honey bees.
Date of Approval: May 30, 1996

NADA 095-143 supplemental approval
Sponsor: Phibro Animal Health.
Generic Name:Oxytetracycline Type A Medicated Article
Trade Name: OXTC®-50, OXTC®-100, and OXTC®-200100MR
Effect of Supplement:This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days
Date of Approval: April 29, 2002

NADA 095-143 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline
Trade Name: Terramycin® 50, Terramycin® 100, Terramycin® 200 Type A Medicated Articles
Indications for use: For increased rate of weight gain and improved feed efficiency; reduction of liver abscesses; for prevention and treatment of the early stages of shipping fever complex; the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline.
Date of Approval: March 12, 2004

NADA 095-735 supplemental approval
Sponsor: Elanco Products Company
Generic Name: monensin (as monensin sodium)
Trade name: Rumensin
Effect of Supplement: This supplement provides for an additional claim for the use of monensin in the prevention and control of coccidiosis in feedlot cattle.
Date of Approval: October 22, 1990

NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly & Co.
Generic Name: monensin sodium
Trade name: Rumensin; 80
Effect of Supplement: This supplemental application provides for a revision of feeding directions, a weight-based dose for prevention and control of coccidiosis, and the establishment of an acceptable daily intake (ADI).
Date of Approval: December 16, 1998

NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly & Co.
Generic Name: monensin sodium
Trade name: Rumensin® 80 Type A Medicated Article
Effect of Supplement: This supplemental application provides for the addition of a claim for the prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii.
Date of Approval: July 7, 2000

NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly & Co.
Generic Name: monensin sodium
Trade name: Rumensin® 80 Type A Medicated Article
Effect of Supplement: To provide a technical amendment to 21 CFR 558.355(f)(3)(vii). The improved feed efficiency claim will be removed from 21 CFR 558.355(f)(3)(vii) and remain separately codified as it appears in 21 CFR 558.355(f)(3)(i). To provide for a revision to the Type C medicated feed label for the prevention and control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in feedlot cattle, changing the concentration of active drug ingredient from 10-200 g/ton of monensin to the correct level of 10 to 30 g/ton of monensin
Date of Approval: December 12, 2003

NADA 096-298 original approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid
Trade Name: Bovatec;
Indications for use: For increased rate of gain and for improved feed efficiency in beef cattle fed in confinement for slaughter.
Date of Approval: August 6, 1982

NADA 096-298 supplemental approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: lasalocid
Trade Name: Bovatec
Effect of Supplement: This supplement provides for use of a Roche formulation of a ruminant free-choice liquid Type C medicated feed for free-choice supplementation of pasture cattle.
Date of Approval: July 26, 1993

NADA 096-298 supplemental approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium
Trade Name: Avatec;
Effect of Supplement: This supplement provides for the use of Avatec; to prevent coccidiosis caused by Eimeria legionensis in chukar partridges.
Date of Approval: April 19, 1995

NADA 096-298 supplemental approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: lasalocid sodium
Trade Name: AVATEC
Effect of Supplement:Adds an additional claim for the prevention of coccidiosis in growing turkeys with a zero (0) day withdrawal time. The use level in feeds approved for broiler chickens at 68 to 113 grams per ton of feed (75-125 ppm) remains the same
Date of Approval: April 28, 1995

NADA 096-298 supplemental approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium
Trade Name: Avatec;
Effect of Supplement: This supplement adds an additional claim for the prevention of coccidiosis in young rabbits.
Date of Approval: October 20, 1995

NADA 096-298 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name: Lasalocid
Trade Name: Bovatec; Type A Medicated Article
Effect of Supplement: This supplement provides for the addition of a species and class (young rabbits) at a new lower concentration.
Date of Approval: February 5, 1999

NADA 096-298 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium
Trade Name: Avatec®
Effect of Supplement: This supplement provides for establishing tolerances for residues in chickens, turkeys and sheep liver and adding an acceptable daily intake (ADI).
Date of Approval: February 20, 2001

NADA 096-298 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium
Trade Name: Bovatec®
Effect of Supplement: This supplement, 21 CFR 558.311, currently provides for the use of lasalocid (1) to improve feed efficiency and increase rate of weight gain in cattle fed in confinement for slaughter, (2) to increase rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers) when fed daily in at least one pound of supplemental feed, and (3) to increase rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers) when lasalocid is provided in a free-choice supplemental feed. .
Date of Approval: July 25, 2001

NADA 096-298 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium
Trade Name: Bovatec®
Effect of Supplement: To provide for the use of lasalocid in a generic free-choice high-phosphorus loose mineral feed containing 1088 grams of lasalocid per ton feed.
Date of Approval: April 9, 200

NADA 097-452 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Oxyject; 100
Effect of Supplement: This supplemental NADA provides for the subcutaneous route of administration and the application of new tolerances (61 FR 67435) to the approved product, Oxyject; 100.
Date of Approval: February 21, 1997

NADA 097-505 supplemental approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomycin Premixes
Effect of Supplement: This supplement provides for the following actions concerning use of Lincomycin in swine feed at the 40 and 20-gram-per-ton levels: (1) removal of the 6-day, preslaughter, drug withdrawal requirement; and (2) removal of the Lincomycin entry from the Category II table and addition of same to the Category I table in 21CFR 558.4.
Date of Approval: May 1, 1990

NADA 097-505 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride monohydrate
Trade Name: Lincomycin; 10/20/50 Feed Medications
Effect of Supplement: Swine - For treatment of swine dysentery. For treatment and control of swine dysentery. For reduction of severity of mycoplasmal pneumonia. For increase in rate of gain in growing-finishing swine. Broiler chickens--For increase of rate of weight gain and feed efficiency. For the control of necrotic enteritis.
Date of Approval: August 25, 1998

NADA 097-505 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: Lincomycin hydrochloride
Trade Name: Lincomycin® 20/50
Effect of Supplement: To add the label claim for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis.
Date of Approval: February 28, 2002

NADA 098-341 original approval
Sponsor: American Hoechst Corporation, Animal Health Division
Generic Name:bambermycins, roxarsone, monensin
Trade Name: Flavomycin;, 3-Nitro, Coban
Indications for use: For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, E. brunetti; For increased rate of weight gain in broiler chickens
Date of Approval: March 4, 1985

NADA 100-901 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: chlortetracycline pre-mix
Trade Name: Pfichlor 100S Milk Replacer Type A Medicated Article
Effect of Supplement: Category II change.
Date of Approval: January 27, 1998

NADA 100-929 original approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: sulfadimethoxine/ormetoprim
Trade Name: Primor Tablets
Indications for use: Primor is to be used in the treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli susceptible to sulfadimethoxine/ormetoprim.
Date of Approval:November 24, 1989

NADA 100-929 supplemental approval
Sponsor:Pfizer Inc.
Generic Name:sulfadimethoxine/ormetoprim
Trade Name:Primor;
Effect of Supplement:This supplemental Application amends the NADA to provide for the use of Primor; Tablets for the treatment of urinary tract infections caused by certaom bacteroa susceptible to sulfadimethoxine/ormetoprim. Primor; Tablets (NADA 100-929) is currently approved for use in dogs.
Date of Approval: August 5, 1996

NADA 101-331 original approval
Sponsor Name: Ralston Purina Co.
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Tablets
Indications for use: For the removal of large roundworms (ascarids), Toxocara canis and Toxascaris leonina and hookworms, Anyclostoma caninum and Uncinaria stenocephala in dogs. The presence of these parasites should be confirmed by laboratory fecal examination. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
Date of Approval: November 14, 1978.

NADA 101-331 supplemental approval
Sponsor: Ralston Purina Company
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Tablets
Effect of Supplement: Will provide for repeat treatment of puppies, lactating bitches and adult dogs for control of T. canis.
Date of Approval:

NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement provides for an additional species, cattle, to be added to the previously approved product, BANAMINE® Injectable Solution.
Date of Approval: May 5, 1998

NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement provides for an additional statement added to the Precaution section of the labeling and a heading change on the label from Warning to Adverse Reactions to the previously approved product labeling for BANAMINE® Injectable Solution.
Date of Approval: May 6, 1998

NADA 101-862 supplemental approval
Sponsor: Schering-Plough Animal Health
Generic Name: gentamicin sulfate veterinary
Trade Name: GARASOL; Injection
Effect of Supplement: This supplement provides for adding the previously approved turkey claims under NADA 47-486 to the labeling of NADA 101-862. The excipients in the formulations are identical, although the quantities are slightly different.
Date of Approval: March 28, 1996

NADA 104-646 original approval
Sponsor: Elanco Products Company
Generic Name: monensin sodium; Tylosin Phosphate
Trade Name: RUMENSIN; TYLAN ;
Indications for use: For improved feed efficiency and for reduction of incidence of liver abscesses in beef cattle caused by Sphaerophorus necrophorus and Corynebacterium pyogenes .
Date of Approval: March 6, 1976

NADA 104-646 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, tylosin phosphate
Trade Name: Rumensin®, Tylan®
Effect of Supplement: provides for the complete range of both individually approved drugs (Type A Medicated Articles) in Type B or C medicated feeds in combination for cattle fed in confinement for slaughter.
Date of Approval: November 19, 1998

NADA 104-646 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, tylosin phosphate
Trade Name: Rumensin®, Tylan®
Effect of Supplement: provides for the treatment of the approved combination of monensin plus tylosin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.
Date of Approval: February 2, 2001

NADA 106-964 original approval
Sponsor: Elanco Products Company
Generic Name: apramycin sulfate
Trade Name: APRALAN; Soluble Powder
Indications for use: APRALAN; Soluble Powder is indicated for the oral treatment of porcine colibacillosis (weanling pig scours) caused by strains of E. coli sensitive to apramycin.
Date of Approval: November 20, 1981

NADA 106-964 supplemental approval
Sponsor: Elanco Products Company
Generic Name: apramycin sulfate
Trade Name: APRALAN; Soluble Powder
Effect of Supplement: Dosage level of 12.5 mg/kg bodyweight (5.7 mg/lb bdwt) daily for 7 days and indications for the control of porcine colibacillosis.
Date of Approval: November 23, 1983

NADA 106-964 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: apramycin sulfate
Trade Name: Apralan;
Effect of Supplement: Assigns an increased acceptable daily intake (ADI) and an increased safe concentration for total apramycin residues in edible tissues.
Date of Approval: June 24, 1997

NADA 107-996 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium, bacitracin methylene disalicylate
Trade Name: Avatec® plus BMD®
Effect of Supplement: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, an E, maxima, and for increased rate of weight gain and improved feed efficiency in broiler and fryer chickens.
Date of Approval: December 4, 2002

NADA 110-048 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: albendazole
Trade Name: Valbazen;
Indications for use: Cattle anthelmintic for the removal and control of endoparasites infecting cattle.
Date of Approval:March 30, 1989.

NADA 110-048 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Albendazole
Trade Name: Valbazen;
Effective Supplement: Provides for the addition of a new species (sheep) at the more concentrated cattle formulation.
Date of Approval:December 02, 1998

NADA 110-315 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name:progesterone plus estradiol benzoate
Trade Name: CALF-oid
Effect of Supplement: This supplement provides for the use of CALF-oid in suckling beef calves (at least 45 days of age) up to 400 lbs. of bodyweight.
Date of Approval:April 5, 1990.

NADA 110-315 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: progesterone and estradiol benzoate
Trade Name: Implus-C;
Effect of Supplement: This supplement provides for the deletion of the present labeling limitation against the use of Implus-C in heifer (suckling beef) calves intended for reproduction.
Date of Approval: January 22, 1997

NADA 110-315 original approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: progesterone, estradiol benzoate and and Tylosin Tartrate
Trade Name: Component; E-S with Tylan;; Component; E-C with Tylan;
Indications for use: Component; E-S with Tylan; : For increased rate of weight gain and improved feed efficiency in steers weighing 400 lbs or more. Component; E-C with Tylan; : For increased rate of weight gain in suckling beef calves up to 400 lbs body weight.
Date of Approval: July 20, 1999

NADA 111-607 supplemental approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit; 5.68% Injectable Solution
Effect of Supplement: This Supplemental Application amends the NADA to provide for the use of Droncit Injectable Solution against Echinococcus multilocularis in dogs.
Date of Approval:July 16, 1993

NADA 111-636 supplemental approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix Soluble Powder
Effect of Supplement: This supplement provides for use of this product in broiler chickens. It also provides for the deletion of the tolerance for lincomycin residues in chickens.
Date of Approval: January 23, 1990

NADA 111-636 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride monohydrate
Trade Name: Lincomix Soluble Powder
Effect of Supplement: This supplemental approval provides for the assignment of a tolerance of 0.6 ppm for lincomycin in swine liver, a tolerance of 0.1 ppm for lincomycin in swine muscle, and the assignment of an Acceptable Daily Intake (ADI) of 25 micrograms per kilograms per body weight per day for the total residues of lincomycin. In addition, this supplement reduces the slaughter period for drinking water uses of lincomycin in swine from 6 days to 0 days.
Date of Approval: August 25, 1998

NADA 111-636 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix Soluble Powder
Effect of Supplement: Provides for revision of the approved LINCOMIX Soluble Powder Insert Labeling replacing a caution for use only in swine weighing less than 250 pounds with a caution indicating safety has not been demonstrated for pregnant swine or swine intended for breeding.
Date of Approval: December 31, 2001

NADA 111-798 supplemental approval
Sponsor: Mobay Corporation, Animal Health Division
Generic Name: praziquantel
Trade Name: CUTTER Tape-Tabs
Effect of Supplement: The purpose of the supplement is to provide for OTC marketing of praziquantel tablets for the indications listed below.
Date of Approval: January 18, 1990

NADA 111-798 supplemental approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit* Feline Cestocide Tablets
Effect of Supplement: This supplement amends the NADA to provide for a 11.5 mg spherical tablet, which is half the concentration of the previously approved 23 mg tablet, for cats.
Date of Approval: January 11, 1993

NADA 111-798 supplemental approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit; 34 mg Canine Tablets
Effect of Supplement: This Supplemental Application amends the NADA to provide for the use of Droncit Tablets against Echinococcus multilocularis in dogs. Droncit Tablets (NADA #111-798, 46 FR 60570 [December 11, 1981]) are currently approved for use in dogs and cats.
Date of Approval: July, 16, 1993

NADA 112-051 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Levamisole hydrochloride
Trade Name: Levasole ®
Effect of Supplement: Used for the following adult nematode infections:
Sheep:
Stomach Worms: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta.
Intestinal Worms: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina.
Lungworms:Dictyocaulus filaria.
Cattle:
Stomach Worms: Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei.
Intestinal Worms: Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum.
Lungworms:Dictyocaulus viviparus.
Date of Approval: December 23, 2003

NADA 113-232 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: Liquamycin; LA-200;
Effect of Supplement: This supplement provides for the codification of a revised tolerance for residues of oxytetracycline in edible tissues.
Date of Approval: March 28, 1996

NADA 113-232 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: Terramycin-10, 20, 50, 50D, 100, 100D, 100SS, & 200
Effect of Supplement: This supplement provides for changes to the product labeling to include a subcutaneous (SC) route of administration in cattle. Also, the indications section of the labeling will be revised to include "pre-ruminating (veal) calves."
Date of Approval: April 23, 1997

NADA 113-232 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: Liquamycin; LA-200;
Effect of Supplement: This supplement provides for changes to the product labeling to include lactating dairy cows. Also, a tolerance for oxytetracycline in milk is established at 0.3ppm.
Date of Approval: July 21, 1998

NADA 115-581 supplemental approval
Sponsor: MoorMan's, Inc
Generic Name: Monensin Sodium
Trade Name: Rumensin®
Effect of Supplement: This supplement provides for the addition of the claim "for the prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii" to MoorMan's Type C monensin medicated free-choice protein-mineral blocks (MoorMan's Mintrate Blonde Block RU and MoorMan's Mintrate Red Block RU).
Date of Approval: September 27, 2001

NADA 116-088 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate, monensin, roxarsone
Trade Name: BMD;/Coban;/3-Nitro;
Effect of Supplement: This supplemental application adds the higher use level of bacitracin methylene disalicylate in broiler chicken feed (100 to 200 grams/ton) associated with the necrotic enteritis control claim which was approved under the single ingredient application (NADA 046-592).
Date of Approval: December 24, 1998

NADA 118-980 supplemental approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin
Trade Name: Monteban®
Effect of Supplement: This supplement provides for the revision of 21 CFR 556.428 by the addition of tolerance for abdominal fat and acceptable daily intake (ADI)
Date of Approval: April 11, 2001

NADA 120-161 supplemental approval
Sponsor: Pharmacia & Upjohn Co
Generic Name: clindamycin hydrochloride
Trade Name: ANTIROBE Capsules
Effect of Supplement: The supplement provides for the use of clindamycin hydrochloride (ANTIROBE Capsules) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition, this supplement provides for the addition of a 300 mg capsule. This supplement also provides for the addition of recent MIC data derived from U.S. diagnostic laboratories.
Date of Approval: May 13, 2002

NADA 120-614 original approval
Sponsor: Webel Feeds, Inc.
Generic Name: Tylosin (as tylosin phosphate) combined with Sulfamethazine
Tradename: Tylan 5, 10, 20, and 40 Sulfa-G.
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes)
Date of approval: May 28, 1985

NADA 120-648 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: fenbendazole
Trade Name: Panacur ; and Safe-Guard;
Date of approval: May 28, 1985

NADA 121-473 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Panacur®; 22.2% Granules
Effect of Supplement: This supplement provides a claim as an anthelmintic in the following species within the families Felidae and Ursidae: lion (Panthera leo), tiger (Panthera tigris) cheetah (Acinonyx jubatus) Puma (Felis concolor), Jaguars (Panthera onca), Leopard (Panthera pardus), Panther (Panthera spp) Grizzly Bear (Ursus horribilis), Polar Bear (Ursus maritimus), and Black Bear (Ursus americanus).
Date of Approval: May 31, 1994

NADA 121-473 supplemental approval
Sponsor: Intervet Inc.
Generic Name: fenbendazole
Trade Name: PANACUR®-C
Effect of Supplement: This supplement provides for a change from prescription (Rx) to OTC status for fenbendazole granules 22.2% packets to be marketed under the trade name PANACUR®-C.  The jar presentation (Panacur®) will remain prescription (Rx) as it is also labeled for use in other species of carnivorous/omnivorous animals.  The jar presentation will continue to be marketed under the Panacur® trade name.
Date of Approval: March 19, 2002

NADA 122-578 supplemental approval
Sponsor: Anika Therapeutics, Inc.
Generic Name:Hyaluronate sodium
Trade Name: Hyvisc; Sterile Injection
Effect of Supplement:To increase the concentration of hyaluronate sodium from 10 mg/mL to 11 mg/mL, and increase the dose from 20 mg to 22 mg for small joints and from 40 mg to 44 mg for large joints.
Date of Approval: September 30, 1998

NADA 124-309 supplemental approval
Sponsor Name: The Upjohn Company
Generic Name: melengestrol acetate and monensin sodium
Trade Name: MGA 100/200 Premix or MGA 500 Liquid Premix and Rumensin
Effect of Supplement: This supplement provides for removal of the requirement for a preslaughter drug withdrawal period for heifers fed melengestrol acetate in combination with monensin. Previous approvals have required a 48-hour preslaughter drug withdrawal for melengestrol acetate.
Date of Approval: June 29, 1994

NADA 124-309 supplemental approval
Sponsor Name: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin sodium
Trade Name: MGA® and Rumensin®
Effect of Supplement: 21 CFR 558.342(d)(2) currently provides for the combination use of melengestrol acetate and monensin to provide 0.25 to 0.4 mg/hd/day of melengestrol acetate and 50 to 360 mg/hd/day monensin for heifers being fed in confinement for slaughter for increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).These supplements provide for the treatment of the approved combination of melengestrol acetate and monensin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.  This effect is to provide for the addition of the claim for prevention and control of coccidiosis on a mg/lb body weight basis for monensin to this combination with melengestrol acetate for Type B and Type C medicated feeds for heifers being fed in confinement for slaughter.
Date of Approval: February 26, 2002

NADA 125-476 supplemental approval
Sponsor Name: The Upjohn Company
Generic Name: melengestrol acetate and monensin sodium
Trade Name: MGA 100/200 Premix or MGA 500 Liquid Premix and Rumensin
Effect of Supplement: This supplement provides for removal of the requirement for a preslaughter drug withdrawal period for heifers fed melengestrol acetate in combination with monensin. Previous approvals have required a 48-hour preslaughter drug withdrawal for melengestrol acetate.
Date of Approval: June 29, 1994

NADA 125-476 supplemental approval
Sponsor Name: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin sodium
Trade Name: MGA® and Rumensin®
Effect of Supplement: 21 CFR 558.342(d)(2) currently provides for the combination use of melengestrol acetate and monensin to provide 0.25 to 0.4 mg/hd/day of melengestrol acetate and 50 to 360 mg/hd/day monensin for heifers being fed in confinement for slaughter for increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).These supplements provide for the treatment of the approved combination of melengestrol acetate and monensin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.  This effect is to provide for the addition of the claim for prevention and control of coccidiosis on a mg/lb body weight basis for monensin to this combination with melengestrol acetate for Type B and Type C medicated feeds for heifers being fed in confinement for slaughter.
Date of Approval: February 26, 2002

NADA 126-050 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: apramycin sulfate
Trade Name: Apralan;75
Effect of Supplement: Increases acceptable daily intake and safe residue concentration levels in edible tissues.
Date of Approval: June 24, 1997

NADA 128-070 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: Albendazole
Trade Name: VALBAZEN;
Indications for Use: Cattle anthelmintic for the removal and control of the following endoparasites and infecting cattle: A. Liver flukes:Fasciola hepatica (adults) B. Tapeworms:Moniezia benedeni, M. expansa (heads and segments) C. Lungworms:Dictyocaulus viviparus (adults and 4th stage larvae) D. Stomach worms: Barberpole worm: Haemonchus contortus, H. placei (adults and 4th stage larvae) Brown stomach worm: Ostertagia ostertagi (adults, 4th stage larvae and 4th stage inhibited larvae) Small stomach worm: Trichostrongylus axei (adults and 4th stage larvae) E. Intestinal worms: Hookworm: Bunostomum phlebotomum (adults) Threadnecked intestinal worm: Nematodirus spathiger, N. helvetianus (adults and 4th stage larvae) Small intestinal worm: Cooperia oncophora, C. punctata (adults and 4th stage larvae) Bankrupt worm: T. colubriformis (adults) Nodular worm: Oesophagostomum radiatum (adults)
Date of Approval: November 17, 1989

NADA 128-255 original approval
Sponsor: Kay Dee Feed Co.
Generic Name: tylosin, sulfamethazine
Trade Name: Tylan 5 Sulfa Premix, Tylan 10 Sulfa Premix
Indications for use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: February 19, 1982

NADA 128-409 supplemental approval
Sponsor Name:MERCK & CO., INC.
Generic Name:Ivermectin
Trade Name:IVOMEC; Injection for Cattle
Effect of Supplement: New tolerance for residues of ivermectin B1a in cattle liver of 100 ppb and revised safe concentration in tissues
Date of Approval: September 13, 1995

NADA 128-409 supplemental approval
Sponsor: Merck & Co., Inc.
Generic Name: ivermectin
Trade Name: Ivomec; Injection for Cattle and Swine
Effect of Supplement: New claims for persistent control of gastrointestinal roundworms and lungworms in cattle.
Date of Approval: February 24, 1997

NADA 128-409 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec; Injection for Cattle and Swine
Effect of Supplement: New claim for the treatment and control of grubs (Hypoderma bovis in American bison.
Date of Approval: December 19, 1997

NADA 128-409 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec; Injection for Cattle and Swine
Effect of Supplement: This supplemental application extends the period of persistent effect against infections of Dictyocaulus viviparus from 21 days to 28 days after treatment, and establishes an ADI in cattle muscle for total residues of ivermectin
Date of Approval: April 1, 1999

NADA 128-409 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: IVOMEC (ivermectin) Injection for Cattle and Swine
Effect of Supplement: To extend the persistent effect periods of Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information and to add the veal calf warning statement to the residue information section.
Date of Approval: August 16, 2004

NADA 128-620 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Generic Name:Panacur
Effect of Supplement: This supplement provides for an expanded use of fenbendazole in a new species (goats).
Date of Approval: April 25, 1994

NADA 128-620 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: Fenbendazole
Trade Name: Safe-Guard; 10% Suspension
Effect of Supplement: This supplement provides for the use of fenbendazole for the removal and control of gastrointestinal parasites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996

NADA 128-620 supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: Fenbendazole
Trade Name: Panacur®, Safe-guard® Suspension 10%
Effect of Supplement: This supplement provides for establishing tolerances for residues of parent fenbendazole in muscle of cattle and goats.
Date of Approval: May 9, 2000

NADA 128-620 supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: Fenbendazole
Trade Name: Panacur®, Safe-guard® Suspension 10%
Effect of Supplement: 1) The marketing status of fenbendazole suspension for use in goats is changed from prescription (Rx) to over-the-counter (OTC) by removing goats from the PanacurÆÊ Suspension 10% label and by adding goats to the Safe-GuardR Suspension 10% label. The formulation of the two products is identical. 2) The indications for use in goats are revised from "for the removal and control of stomach and intestinal worms Haemonchus contortus and Ostertagia circumcincta" to "for the removal and control of stomach worms (adults) Haemonchus contortus and Teladorsagia circumcincta.¨
Date of Approval: February 13, 2003

NADA 128-686 supplemental approval
Sponsor: Agri-Bio Corporation
Generic Name: salinomycin sodium
Trade Name: Bio-Cox;
Date of Approval: September 1, 1994

NADA 128-686 supplemental approval
Sponsor: Hoffmann-La Roche
Generic Name: salinomycin sodium
Trade Name: Bio-Cox;
Effect of Supplement: To add roaster and replacement (breeder and layer) chickens to the label claim for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
Date of Approval: February 3, 1997

NADA 130-435 supplemental approval
Sponsor: I.D. Russell Company, Laboratories
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTET SOLUBLE
Effect of Supplement: This supplement provides for use of this product in swine.
Date of Approval: December 10, 1993

NADA 130-435 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Oxytet Soluble, Tetravet-CA
Effect of Supplement: This supplement provides for a revised withdrawal time of oxytetracycline hydrochloride soluble powder in the drinking water of turkeys and swine.
Date of Approval: November 29, 2000

NADA 130-435 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: OxyMarine
Effect of Supplement: To add a claim for the marking of skeletal marking of tissues of all finfish fry and fingerlings
Date of Approval: December 24, 2003

NADA 130-736 supplemental approval
Sponsor: Elanco Products Company
Generic Name: monensin
Trade Name: COBAN;
Effect of Supplement: This supplemental NADA (130-736) provides for a change in treatment regimen from a ten-week feeding period to a continuous feeding for growing turkeys.
Date of Approval: March 23, 1990

NADA 130-951 supplemental approval
Sponsor: Roussel Uclaf, Div. Agro-Veterinaire
Generic Name: halofuginone hydrobromide
Trade Name: Stenorol;
Effect of Supplement: Change of tolerance.
Date of Approval: March 8, 1991

NADA 130-951 supplemental approval
Sponsor: Roussel-Uclaf
Generic Name: halofuginonc hydrobromide
Trade Name: STENOROL;
Effect of Supplement: This supplemental submission has been filed to provide for the same dose level of 2.72 g/t (3 ppm) to be fed to replacement cage laying chickens and replacement broiler breeder chickens for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. aacervulina, E. maxima, E. brunetti, and E. mivati / mitis.
Date of Approval: September 19, 1994

NADA 131-310 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: altrenogest
Trade Name: Regu-Mate; for Horses
Effect of Supplement: This supplement provides for label and package insert changes. This supplement does not affect the status of the original approval and Regu-Mate; (altrenogest) remains a "by prescription only" product.
Date of Approval: June 20, 1990

NADA 131-392 original approval
Sponsor: Merck Sharp and Dohme Research Laboratories
Generic Name:ivermectin
Trade Name: Ivomec; Liquid for Sheep
Indications for use: For the control of certain gastrointestinal nematodes, lungworms, and nasal bots in sheep.
Date of Approval: July 26, 1988

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD; (Premix)
Effect of Supplement:This supplement provides for an additional Type A medicated article (premix) containing 8% fenbendazole for the same indications for use in Type C medicated swine feed as the currently approved Type A medicated articles containing 4% and 20% fenbendazole. See 21 CFR 558.258.
Date of Approval: March 30, 1991

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard ;
Effect of Supplement: This supplemental approval provides for the minor use
claim as a dewormer in specific hoofed zoo and wildlife animals.
Date of Approval: November 20, 1990

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: fenbendazole
Trade Name: Safe-Guard® (fenbendazole)
Effect of Supplement: This supplement provides for the revision 21 CFR 556.275 by establishing tolerances for residues in swine liver and muscle and adding allowable daily intake (ADI).
Date of Approval: February 10, 2000

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: fenbendazole
Trade Name: Safe-Guard®
Effect of Supplement: This supplement provides for the addition of growing turkeys to the previously approved SAFE-GUARD® Type A medicated article labeling.
Date of Approval: July 3, 2000

NADA 131-675 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: fenbendazole
Trade Name: Safe-Guard®
Effect of Supplement: This supplement to NADA 131-675 provides for a new claim for control of gastrointestinal worms in horses [large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris equorum)].
Date of Approval: March 14, 2003

NADA 132-337 supplemental approval
Sponsor: Miles, Inc.
Generic Name: cythioate
Trade Name: Proban ; 90 mg tablets
Effect of Supplement: This supplement amends the NADA to provide for a 90 mg tablet and minor labeling changes. The currently approved tablet is 30 mg.
Date of Approval: April 25, 1994

NADA 132-872 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard; Paste 10%; Panacur; Paste 10%
Effect of Supplement: This supplement provides for the use of fenbendazole for the removal and control of gastrointestinal parasites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996

NADA 133-953 supplemental approval
Sponsor: Mobay Corporation
Generic Name: Febantel and Praziquantel
Trade Name: Vercom Paste Anthelmintic
Effect of Supplement: This supplement provides for the addition of the following warning statement to the label: "Warning: Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction."
Date of Approval: September 12, 1991

NADA 134-314 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: EQVALAN® Paste 1.87%
Effect of Supplement:The supplement provides for the use of ivermectin paste for the treatment and control of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus spp. including: Coronocyclus coronatus, and Coronocyclus labratus. Also, the label descriptions of some currently-approved parasite genera are being revised to add included species for which data already exists in the NADA file and to reflect changes in scientific nomenclature.
Date of Approval: April 2, 2003

NADA 134-779 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: morantel tartrate
Trade Name: Paratect Flex(TM)
Effect of Supplement:This supplemental application provides an additional dosage form for the Morantel tartrate cartridge (Paratect Cartridge) which has been approved since 1984 under this same NADA.
Date of Approval: March 25, 1991

NADA 134-830 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin zinc, monensin sodium
Trade Name: Albac;, Coban;
Indications For Use: As an aid in prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima and E. mivati; for increased rate of weight gain, and for improved feed efficiency in broiler chickens.
Date of Approval: September 1, 1992

NADA 135-321 supplemental approval
Sponsor: Roche Vitamins & Fine Chemicals
Generic Name: salinomycin sodium, bacitracin methylene disalicylate, roxarsone
Trade Name: Bio-Cox;, BMD;, 3-Nitro;
Effect of Supplement: Category II supplemental change providing for an additional use level of roxarsone.
Date of Approval: May 5, 1997

NADA 135-906 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Testosterone propionate, estradiol benzoate, tylosin tartr
Trade Name: Component; E-H with Tylan;
Effect of Supplement: This supplement provides for the use of clindamycin HCl (ANTIROBE AQUADROPS Liquid) in cats for new indications.
Date of Approval: July 20, 1999

NADA 135-940 supplemental approval
Sponsor: Pharmacia and Upjohn
Generic Name: clindamycin hydrochloride
Trade Name: ANTIROBE AQUADROPS Liquid
Effect of Supplement: The supplement provides for the use of clindamycin hydrochloride (ANTIROBE AQUADROPS Liquid) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition, this supplement provides for an expanded dose range of 5-15 mg/lb every 24 hours in cats. This supplement also provides for the addition of recent MIC data derived from a survey of U.S. diagnostic laboratories.
Date of Approval: May 13, 2002

NADA 135-940 supplemental approval
Sponsor: Pharmacia and Upjohn
Generic Name: Clindamycin hydrochloride oral liquid
Trade Name: ANTIROBE AQUADROPS
Effect of Supplement: This supplement provides for the use of clindamycin HCl (ANTIROBE AQUADROPS Liquid) in cats for new indications.
Date of Approval:
October 7, 1996

NADA 135-940 supplemental approval
Sponsor: The Upjohn Co
Generic Name: Clindamycin hydrochloride oral liquid
Trade Name: Antirobe Aquadrops
Effect of Supplement: This supplemental application provides for the following additional claims: Aerobic bacteria: for the treatment of dental infections caused by susceptible strains of Staphylococcus aure us. Anaerobic bacteria: for the treatment of soft tissue infections (deep wounds and abscesses), dental infections, and osteomyelitis caused by or associated with susceptible strains of Bacteroides fragilis, Bacteroides melaninogenicus, Fusobacterium necrophorumand Clostridium perfringens.
Date of Approval:
November 16, 1989

NADA 136-483 supplemental approval
Sponsor: Norden Laboratories
Generic Name: diethylcarbamazine citrate and oxibendazole chewable tablets
Trade Name: Filaribits; Plus Chewable Tablets
Effect of Supplement: Results in the addition of a label statement to provide for the removal and control of mature and immature stages of intestinal Toxocara canis (ascarid infection). Adequate data showing efficacy for the additional use has been submitted in the supplemental application which is the subject of this approval.
Date of Approval: January 18, 1989

NADA 136-742 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Clorsulon
Trade Name: Curatrem® Drench
Effect of Supplement: This supplement provides for the revision of 21 CFR 556.163 by the addition of tolerance in muscle of cattle and acceptable daily intake (ADI) and deletion of safe concentrations.
Date of Approval: May 16, 2001

NADA 137-537 original approval
Sponsor: A.H. Robins Company
Generic Name: salinomycin and lincomycin
Trade Name: Bio-Cox and Lincomix;
Indications For Use: Anticoccidial and Growth Promotant. Note: This application provides for the combined use of two currently approved Type A medicated articles in the manufacture of Type C medicated feeds for broiler chickens.
Date of Approval: May 22, 1989

NADA 137-600 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD(TM)
Effect of Supplement: The original approval for this NADA provided for the use of Type A Medicated Article in complete feeds for cattle for the removal and control of the listed parasites. The Type "C" medicated complete feed was fed as a single dose of 5 mg fenbendazole per kilogram of body weight. This supplemental submission has been filed to provide for that same dosage of 5 mg/kg body weight to be fed free-choice in a vitamin/mineral supplement (Type C feed) administered over a three to six day period for the removal and control of the listed parasites
Date of Approval: August 30, 1989

NADA 137-600 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard; 20% Type "A" Medicated Article (Premix) 0.5% Cattle Top Dress 35% Free-Choice Mineral
Effect of Supplement: This supplement provides for the use of fenbendazole for the removal and control of gastrointestinal parastites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996

NADA 137-687 supplemental approval
Sponsor: Natchez Animal Supply Company
Generic Name: Formalin, approximately 37% by weight of formaldehyde gas
Trade Name: FORMALIN-F™
Effect of Supplement: Provides for the use of FORMALIN-Fä to be expanded, as a parasiticide, to all finfish and penaeid shrimp, and, as a fungicide, to the eggs of all finfish
Date of Approval: November 25, 2002

NADA 138-187 original approval
Sponsor: Micro Chemical, Inc.
Generic Name: Tylosin (as tylosin phosphate)
Trade Name: Tylan 10, 40 and 100 Premix
Indications for Use: Swine: For increased rate of weight gain and improved feed efficiency. For prevention of swine dysentery (vibrionic). For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. For the treatment and control of swine dysentery (vibrionic) following initial medication of Tylan Plus Vitamins in drinking water. Beef Cattle:For reduction of the incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes. Chickens: For increased rate of weight gain and improved feed efficiency. Laying Chickens: Improving feed efficiency. Broiler and Replacement Chickens: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.
Date of Approval: August 6, 1985

NADA 138-255 original approval
Sponsor: Veterinary Laboratories, Inc.
Generic Name: iron hydrogenated dextran injection
Trade Name: Iron Hydrogenated Dextran Injection
Incations for use: For the prevention and treatment of anemia due to iron deficiency in baby pigs.
Date of Approval: August 6, 1985

NADA 138-342 original approval
Sponsor: Feed Service Co., Inc.
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Indications for use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens(Pasteurella multocida and/or Corynebacterium pyogenes). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: June 11, 1985

NADA 138-405 original approval
Sponsor: Anthony Products Company
Generic Name: pyrilamine maleate injection
Trade Name: Pyrilamine Maleate Injection
Indications for use: For use in horses for treatment of conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease, such as laminitis.
Date of Approval: November 17, 1986

NADA 138-412 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin tablets
Trade Name: HEARTGARD-30;
Indications for use: For use in dogs to prevent canine heartworm disease. HEARTGARD-30 (ivermectin) eliminates the tissue stage of heartworm larvae (Dirofilaria immitis ).
Date of Approval: March 2, 1987

NADA 138-453 original approval
Sponsor: Southern Micro Blenders, Inc.
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Indications for use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: June 18, 1985

NADA 138-454 original approval
Sponsor: JR Specialty Supply Company
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Indications for use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: December 10, 1985

NADA 138-455 original approval
Sponsor: Squire Laboratories, Inc.
Generic Name: 0.2% nitrofurazone dressing (water soluble)
Trade Name: Fura-Zone Solution, Brand of Nitrofurazone Soluble Dressing
Indications for use: For use only on dogs, cats, and horses (not intended for food use). For the prevention or treatment of surface bacterial infections of wounds, burns, cutaneous ulcers and abscesses after incision.
Date of Approval: February 18, 1987

NADA 138-456 original approval
Sponsor: A.L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate, monensin sodium
Trade Name: BMD;, Coban;
Indications for use: For improved feed efficiency and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima and E. mivati . Bacitracin methylene disalicylate 4-50 grams per ton in combination with 110 grams per ton monensin.
Date of Approval: December 17, 1986

NADA 138-456 supplemental approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate and monensin sodium
Trade Name: BMD, Coban
Effect of Supplement:Monensin Sodium is presently approved for use in broiler chicken feed at 90-110 per ton as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima (21 CFR 558.355(f)(1)(i)). Monensin Sodium is presently approved for use in broiler chicken feed at 110 grams per ton in combination with bacitracin methylene disalicylate at 4-50 grams per ton for improved feed efficiency and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima (21 CFR 558-355(f)(1)(xxiv)). This supplemental NADA provides data to support the request for Monensin Sodium to be used at a range of 90-110 grams per ton in combination with bacitracin methylene disalicylate at 4-50 grams per ton for improved feed efficiency and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima.
Date of Approval: February 19,1992

NADA 138-612 original approval
Sponsor: Roussel-Uclaf
Generic Name: trenbolone acetate
Trade Name: Finaplix;
Indications for use: The product is an implanted anabolic agent with slow release of trenbolone acetate which increases rate of weight gain and improves feed efficiency in growing finishing heifers and improves feed efficiency in growing finishing steers.
Date of Approval: July 2, 1986

NADA 138-656 original approval
Sponsor: Farmland Industries, Inc.
Generic Name: pyrantel tartrate
Trade Name: BN Wormer-19.2 Banminth Premix
Indications For Use: 1. Continuous Feeding Program: For aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; for aid in the prevention of establishment of nodular worm (Oesophagostomum) infections of swine. Feed continuously as the sole ration. 2. 3-Day Therapeutic Program: For the removal and control of large roundworm (Ascaris suum) infections of swine. Feed for three days as the sole ration. 3. Single Therapeutic Program: For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections of swine.
Date of Approval: October 4, 1985

NADA 138-657 original approval
Sponsor: VET LABS Limited, Inc.
Generic Name: nitrofurazone ointment
Trade Name: Nitrofurazone Ointment
Indications for use: For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers of dogs, cats, and horses (not for food use).
Date of Approval: May 19, 1987

NADA 138-703 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name:bacitracin zinc, roxarsone, and monensin sodium
Trade Name: Albac;, 3-Nitro;, and Coban;
Indications for use: For improved feed efficiency and as an aid in prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati.
Date of Approval: September 15, 1986

NADA 138-792 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin sodium, tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix, Rumensin;, Tylan;
Indications for use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: August 6, 1990

NADA 138-792 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate, monensin sodium, tylosin phosphate
Trade Name: MGA®, Rumensin®, and Tylan®
Effect of Supplement: These supplements provide for the treatment of the approved combination of melengestrol acetate, monensin and tylosin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.  The effect is to provide for the addition of the coccidiosis claim for monensin (0.14 to 0.42 mg/lb body weight depending on the severity of the challenge, up to 360 mg/hd/day) and the addition of the complete tylosin dose range (60 to 90 mg/hd/day) to this combination with melengestrol acetate for heifers being fed in confinement for slaughter.
Date of Approval: February 26, 2002

NADA 138-792 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA® 100/200 Premix, MGA® 500 Liquid Premix, RUMENSIN®, TYLAN®
Effect of Supplement:This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination with tylosin or with tylosin and monensin. Previous approvals have required a 48 hour pre-slaughter drug withdrawal for heifers fed melengestrol acetate when fed in combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994

NADA 138-828 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: virginiamycin, salinomycin
Trade Name: Stafac; lO,20,50, and 500 Type A Medicated Article; Bio-Cox; Type A Medicated Article
Indications for use: Feed continuously as sole ration to broiler chickens. For increased rate of weight gain, improved feed efficiency and the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati : Stafac; (virginiamycin) 5g/ton ,Bio-Cox; (salinomycin) 40-60g/ton. For increased rate of weight gain and the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati :Stafac; (virginiamycin) 5-15g/ton, Bio-Cox; (salinomycin) 40-60g/ton. This approval does not provide for a single Type A Medicated Article containing both virginiamycin and salinomycin.
Date of Approval: September 13, 1988

NADA 138-869 original approval
Sponsor: Med-Tech, Inc.
Generic Name: triamcinolone acetonide
Trade Name: Triamcinolone Acetonide Injection, 2 mg/ml & 6 mg/ml
Indications For Use: Triamcinolone acetonide is a highly potent glucocorticoid effective in the treatment of inflammation and related disorders in dogs, cats and horses. It is also indicated for use in the management and treatment of acute arthritis and allergic and dermatologic disorders in dogs and cats.
Date of Approval: January 6, 1987

NADA 138-870original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin sodium, tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix, Rumensin;, Tylan;
Indications for use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: August 6, 1990

NADA 138-870 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate, monensin sodium, tylosin phosphate
Trade Name: MGA®, Rumensin®, and Tylan®
Effect of Supplement: These supplements provide for the treatment of the approved combination of melengestrol acetate, monensin and tylosin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.  The effect is to provide for the addition of the coccidiosis claim for monensin (0.14 to 0.42 mg/lb body weight depending on the severity of the challenge, up to 360 mg/hd/day) and the addition of the complete tylosin dose range (60 to 90 mg/hd/day) to this combination with melengestrol acetate for heifers being fed in confinement for slaughter.
Date of Approval: February 26, 2002

NADA 138-870 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix, RUMENSIN;, TYLAN;
Effect of Supplement:This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination with tylosin or with tylosin and monensin. Previous approvals have required a 48 hour pre-slaughter drug withdrawal for heifers fed melengestrol acetate when fed in combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994

NADA 138-900 original approval
Sponsor: Richlyn Laboratories, Inc.
Generic Name: dichlorophene/toluene capsules
Trade Name: Dichlorophene/Toluene Capsules (Wormer for Dogs and Cats)
Indications For Use: For removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) and as an aid in removal of tapeworms (Taenia pisiformis, Dipylidium caninum, and Echinococcus granulosus) from dogs and cats.
Date of Approval: October 22, 1987

NADA 138-902 original approval
Sponsor: Schering Animal Health
Generic Name: tioxidazole
Trade Name: Tiox Paste
Indications for use: Tiox (tioxidazole) Paste is indicated for removal of mature large strongyles (Strongylus edentatus, S.equinus , and S.vulgaris ), mature ascarids (Parascaris equorum and immature (4th larval stage) pinworms (Oxyuris equi ), and mature small strongyles (Triodontophorus spp ).
Date of Approval: November 9, 1987

NADA 138-903 original approval
Sponsor: Syntex Agribusiness, Inc.
Generic Name: fenprostalene
Trade Name: Porcilene; (fenprostalene) sterile solution
Indications for use: Porcilene; (fenprostalene) sterile solution is indicated for use in sows and gilts pregnant at least 112 days for the induction of parturition.
Date of Approval: December 23, 1988

NADA 138-904 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid sodium, tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix, Bovatec;, Tylan;
Indications for use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: August 6, 1990

NADA 138-904 supplemental approval
Sponsor: The Upjohn Company
Generic Names: melengestrol acetate, lasalocid, tylosin
Trade Names: MGA; 100/200 Premix, MGA; 500 Liquid Premix, BOVATEC;, TYLAN;
Effect of Supplement:This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination either with lasalocid or with lasalocid and tylosin. Previous approvals have required a 48 hour pre-slaughter drug withdrawal for heifers fed melengestrol acetate when fed in combination with these drugs.
Date of Approval: June 29, 1994

NADA 138-935 supplemental approval
Sponsor: Pennfield Oil Company
Generic Name: chlortetracycline Type A medicated article
Trade Name: CHLORTETRACYCLINE, 50, 60, 70, 80, 100 & 100MR
Effect of Supplement: The effect of this Category II supplement is to bring the drug product into compliance with the National Academy of Science/National Research Council/ Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996

NADA 138-935 supplemental approval
Sponsor: PennfField Oil Company
Generic Name: Chlortetracycline Pre-mix
Trade Name: Pennchlor Type A Medicated Article
Effect of Supplement: Changes the withdrawal time from 10 days to one day withdrawal period for cattle
Date of Approval: March 24 1999

NADA 138-938 original approval
Sponsor: Pennfield Oil Company
Generic Name:oxytetracycline pre-mix
Trade Name: Oxytetracycline 50, 100 & 100MR
Indications for use: For the control and treatment of specific diseases susceptible to oxytetracycline pre-mix in swine, calves, cattle, chickens, turkeys, sheep, and honey bees.
Date of Approval: March 15, 1996

NADA 138-941 original approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride/pyrantel tartrate
Trade Name: Lincomix;/Banminth;
Indications for use: For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae ; aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; aid in the prevention of establishment of nodular worm (Oesophaqostomum spp ) infections of swine when fed in accordance with directions for use.
Date of Approval: December 11, 1985

NADA 138-952 original approval
Sponsor: Elanco Products Company
Generic Name: narasin and nicarbazin
Trade Name: MAXIBAN;
Indications for use: For the prevention of coccidiosis in broiler chickens caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima .
Date of Approval: January 18, 1989

NADA 138-953 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: virginiamycin, salinomycin, roxarsone
Trade Name: Stafac; 500 Type A Medicated Article, Stafac; 50 Type A Medicated Article, Stafac; 20 Type A Medicated Article, Stafac; lO Type A Medicated Article, Bio-Cox;Type A Medicated Article, 3-Nitro;-10, 3-Nitro;-20, 3-Nitro;-50 , 3-Nitro;-80 Type A Medicated Articles
Indications for use: Feed continuously as sole ration to broiler chickens. For improved feed efficiency, for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella which are more susceptible to roxarsone combined with salinomycin than to salinomycin alone.This approval does not provide for a single Type A Medicated Article containing virginiamycin, salinomycin and roxarsone.
Date of Approval: November 1, 1988

NADA 138-954 original approval
Sponsor: Pitman-Moore, Inc.
Generic Name: mebendazole and trichlorfon
Trade Name: TELMIN(TM) B Paste Equine Wormer
Indications for use: TELMIN B Paste is indicated in the treatment of infections caused by bots (Gastrophilus intestinalis and G. nasalis ), large roundworms (Parascaris equorum ), large strongyles (Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles and pinworms (Oxyuris equi ).
Date of Approval: April 18, 1986

NADA 138-955 original approval
Sponsor: Medico Industries, Inc.
Generic Name: tylosin Injection
Trade Name: Tylosin Injection, 50 mg/ml & 200 mg/ml
Indications for use: BOVINE: indicated for use in the treatment of respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Corynebacterium pyogenes ; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Corynebacterium pyogenes in beef cattle and nonlactating dairy cattle. SWINE: indicated for use in the treatment of arthritis caused by Mycoplasma hyosynoviae ; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae ; acute swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.
Date of Approval: December 10, 1985

NADA 138-992 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid sodium, tylosin phosphate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix, Bovatec;, Tylan;
Indications for use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: August 6, 1990

ANADA 138-992 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA; Premixes
Effect of Supplement: This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination either with lasalocid or with lasalocid and tylosin.
Date of Approval: June 29, 1994

NADA 138-993 original approval
Sponsor: Moorman Mfg. Company
Generic Name: lasalocid
Trade Name: MoorMan's Cattle Minerals BT Medicated
Indications for use: For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
Date of Approval: May 13, 1987

NADA 138-995 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate and tylosin phosphate
Trade Name: MGA ; - 100/200 Premix and MGA; - 500 Liquid Premix and Tylan;
Indications for use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: August 8, 1990

NADA 138-995 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix, RUMENSIN;, TYLAN;
Effect of Supplement: This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination with tylosin or with tylosin and monensin. Previous approvals have required a 48 hour pre-slaughter drug withdrawal for heifers fed melengestrol acetate when fed in combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994

NADA 139-075 original approval
Sponsor: American Cyanamid Company
Generic Name: maduramicin ammonium
Trade Name: CYGRO; 1% Type A Medicated Article
Indications for use: For use in the manufacture of broiler chicken feeds. For the prevention of coccidiosis in broiler chickens caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix and E. mivati.
Date of Approval: February 2, 1989

NADA 139-189 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD;
Effect of Supplement: The original approval provided for a 25 lb. medicated molasses block containing 750 milligrams of fenbendazole per pound as a beef cattle anthelmintic. The molasses block requires an 11-day withdrawal. This supplemental approval provides for a 33-1/2 pound cold press medicated 20% protein feedblock containing 750 milligrams of fenbendazole per pound as a beef cattle anthelmintic. The cold press 20% protein block requires a 16-day withdrawal period.
Date of Approval: May 15, 1989

NADA 139-190 original approval
Sponsor: International Minerals & Chemical Corporation
Generic Name: bacitracin zinc - salinomycin sodium - roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
Trade Name: Baciferm; - Bio-Cox; - 3-Nitro;
Indications for use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti , and E. mivati; for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 5, 1986

NADA 139-191 original approval
Sponsor: Purina Mills, Inc.
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Chewable Tablets
Indications for Use: For removal of ascarids (Toxocara canis; Toxascaris leonina) and hookworms (Ancylostoma caninum; Uncinaria stenocephala) in dogs and puppies. To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
Date of Approval: October 13, 1987

NADA 139-192 original approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate and tylosin phosphate
Trade Name: MGA ; - 100/200 Premix and MGA; - 500 Liquid Premix and Tylan;
Indications for use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: August 8, 1990

NADA 139-192 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA;100/200 Premix, MGA;500 Liquid Premix, RUMENSIN;, TYLAN;
Effect of Supplement:This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination with tylosin or with tylosin and monensin. Previous approvals have required a 48 hour pre-slaughter drug withdrawal for heifers fed melengestrol acetate when fed in combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994

NADA 139-235 original approval
Sponsor: International Minerals & Chemical Corporation
Generic Name: bacitracin zinc - salinomycin sodium
Trade Name: Baciferm; - Bio-Cox;
Indications for use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate of weight gain.
Date of Approval: May 19, 1986

NADA 139-236 supplemental approval
Sponsor: VET-A-MIX, Inc.
Generic Name: xylazine injectable solution, 20 mg/ml
Trade Name: AnaSed(TM), Injectable Solution
Effect of Supplement: Supplement provides for use of the product in an additional species (dog).
Date of Approval: April 24, 1990

NADA 139-236 supplemental approval
Sponsor: Lloyd, Inc.
Generic Name: xylazine hydrochloride
Trade Name: AnaSed; Injectable, 20 mg/mL
Effect of Supplement:This supplement provides for modification of the labeling to include use of AnaSed® 20 mg/mL in cats.
Date of Approval: May 16, 1995

NADA 139-236 supplemental approval
Sponsor: Lloyd, Inc.
Generic Name: xylazine 100 mg/mL
Trade Name: AnaSed; Injectable
Effect of Supplement:This supplement provides for modification of the labeling to include use of AnaSed; 100 mg/mL in Fallow Deer, Mule Deer, Sika Deer, White-tailed Deer, and Elk.
Date of Approval: May 16, 1995

NADA 139-236 supplemental approval
Sponsor: Lloyd, Inc.
Generic Name: xylazine 100 mg/mL
Trade Name: AnaSed; Injectable
Effect of Supplement: This supplement provides for a 300 mg/mL xylazine concentration, in addition to the approved concentration of 100 mg/mL for Cervidae.
Date of Approval: February 10, 2003

NADA 139-237 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: gonadorelin hydrochloride
Trade Name: Factrel;
Indications for use: Factrel; is indicated for the treatment of ovarian follicular cysts in cattle. The treatment effect of Factrel; when used in cattle with ovarian cysts is a reduction in the number of days to first estrus.
Date of Approval: November 11, 1989

NADA 139-239 original approval
Sponsor: Growmark, Inc.
Generic Name: pyrantel tartrate
Trade Name: SWINE-GUARD-BN Banminth Premixes
Indications for Use:
CONTINUOUS FEEDING PROGRAM: For aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; for aid in the prevention of establishment of nodular worm (Oesophagostomum) infections of swine. Feed continuously as the sole ration. 3-DAY THERAPEUTIC PROGRAM: For the removal and control of large roundworm (Ascaris suum) infections of swine. Feed for three days as the sole ration. SINGLE THERAPEUTIC PROGRAM: For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections of swine. Withdraw this feed 24 hours prior to slaughter.
Date of Approval: November 18, 1995

NADA 139-301 original approval
Sponsor: Walnut Grove Products
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premix
Indications for use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Borderella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: November 22, 1985

NADA 139-472 original approval
Sponsor: Fermenta Animal Health Co.
Generic Name: tiamulin
Trade Name: DENAGARD Antibiotic Premix (Type A Medicated Article) DENAGARD 5 Medicated Premix (Type A Medicated Article) DENAGARD 10 Medicated Premix (Type A Medicated Article)
Indications for use: For the control of swine dysentery associated with Treponema hyodysenteriaesusceptible to tiamulin. For increased rate of weight gain from weaning to 125 pounds body weight.
Date of Approval: July 17, 1987

NADA 139-472 supplemental approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin hydrogen fumarate
Trade Name: DENAGARD; Antibiotic Premix, DENAGARD; 5 Medicated Premix, DENAGARD; 10 Medicated Premix (Type A Medicated Articles)
Effect of Supplement: To add the label claim for treatment of swine dysentery at 200 g/ton for 14 days.
Date of Approval: July 7, 1994

NADA 139-472 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: tiamulin hydrogen fumarate
Trade Name: Denagard® (Tiamulin) Medicated Premix
Effect of Supplement: This supplemental application amends the approved NADA to provide for the use of DENAGARD® (Tiamulin) Type A Medicated Article "for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis."
Date of Approval: November 26, 2001

NADA 139-473 original approval
Sponsor: American Hoechst Corporation
Generic Name:virginiamycin; halofuginone hydrobromide
Trade Name: Stafac, Stenorol ;
Indications for use: For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, E. brunetti; For increased rate of wweight gain; For improved feed efficiency in broiler chickens.
Date of Approval: April 22, 1986

NADA 139-488 original approval
Sponsor: Stutts Scientific Service, Inc.
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications For Use: SWINE: For increased rate of weight gain and improved feed efficiency. For prevention of swine dysentery (vibrionic). For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. For the treatment and control of swine dysentery (vibrionic) following initial medication of Tylan Plus Vitamins in drinking water. BEEF CATTLE: For reduction in the incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes. CHICKENS: For increased rate of weight gain and improved feed efficiency. LAYING CHICKENS: Improving feed efficiency. BROILER AND REPLACEMENT CHICKENS: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.
Date of Approval: June 23, 1986

NADA 139-600 original approval
Sponsor: Arkansas Micro Specialties, Inc.
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications for use: SWINE: For increased rate of weight gain and improved feed efficiency. For prevention of swine dysentery (vibrionic). For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. For treatment and control of swine dysentery (vibrionic) following initial medication of Tylan Plus Vitamins in drinking water. BEEF CATTLE: For reduction of incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes. CHICKENS: For increased rate of weight gain and improved feed efficiency. LAYING CHICKENS: Improving feed efficiency. BROILER AND REPLACEMENT CHICKENS: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum. Feeds containing tylosin at 800 to 1000 grams per ton must be withdrawn five days before chickens are slaughtered.
Date of Approval: February 19, 1986

NADA 139-601 original approval
Sponsor: Arkansas Micro Specialties, Inc.
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Indications for use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptical rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: February 19, 1986

NADA 139-633 original approval
Sponsor: Wildlife Laboratories, Incorporated
Generic Name: carfentanil citrate
Trade Name: WILDNIL
Indications for use: For use as an immobilizing agent in free-ranging or confined members of the family Cervidae (deer, elk, moose).
Date of Approval: September 26, 1988

NADA 139-858 original approval
Sponsor: American Cyanamid Company
Generic Name: levamisole resinate and famphur
Trade Name: TRAMISOL; X-TRA
Indications for use: For treatment of cattle infected with the following parasites: STOMACH WORMS: Haemonchus, Trichostrongylus, Ostertagia ; INTESTINAL WORMS: Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ; LUNGWORMS: Dictyocaulus ; BITING LICE: Bovicola ; SUCKING LICE: Linognathus, Solenoptes . It is not effective against lice eggs.
Date of Approval: June 16, 1988

NADA 139-876 original approval
Sponsor: The Upjohn Company, Agricultural Division
Generic Name:melengestrol acetate
Trade Name: MGA; 100/200 Premix, MGA; 500 Liquid Premix
Indications for use: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat) in heifers fed in confinement for slaughter.
Date of Approval: September 8, 1987

NADA 139-876 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid, tylosin
Trade Name: MGA;100/200 Premix, MGA;500 Liquid Premix, BOVATEC;, TYLAN;
Effect of Supplement: This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination either with lasalocid or with lasalocid and tylosin. Previous approvals have required a 48 hour pre-slaughter drug withdrawal for heifers fed melengestrol acetate when fed in combination with these drugs.
Date of Approval: June 29, 1994

NADA 139-877 original approval
Sponsor: Pitman-Moore, Inc.
Generic Name: levamisole
Trade Name: Totalon™ Topical Cattle Anthelmintic
Indications for use: Broad spectrum anthelmintic effective against certain stomach worm, intestinal worm, and lung worm nematode infections in cattle.
Date of Approval: April 6, 1987

NADA 139-879 original approval
Sponsor: Wildlife Laboratories
Generic Name: carnidazole
Trade Name: Spartrix
Indications for use: Spartrix (Carnidazole) is indicated for oral treatment of trichomoniasis (canker) in ornamental and homing (non-food) pigeons.
Date of Approval: July 31, 1989

NADA 139-913 original approval
Sponsor: Solvay Veterinary, Inc.
Generic Name: hyaluronate sodium
Trade Name: Equron
Indications for use: Equron is indicated for the treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis.
Date of Approval: July 10, 1986