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
