ANADA 200-007 original approval
Sponsor: Happy Jack®; Inc.
Generic Name:pyrantel pamoate
Trade Name: Liqui-Vict 2X™
Indications for use: To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
For removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies.
Date of Approval: October 30, 1996

ANADA 200-008 original approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200, BIO-MYCIN® 200
Indications for use: OXY-TET 200/BIO-MYCIN 200 is intended for use in the treatment of the following diseases in beef cattle, nonlactating dairy cattle and swine when due to oxytetracycline susceptible organisms. CATTLE: OXY-TET 200 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis ; foot rot and diphtheria caused by Fusobacterium necrophorum ; bacterial enteritis (scours) caused by Escherichia coli ; wooden tongue caused by Actinobacillus lignieresi ; leptospirosis caused by Leptospira pomona ; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. SWINE: In swine, OXY-TET 200 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli ; pneumonia caused by Pasteurella multocida ; and leptospirosis caused by Leptospira pomona . In sows, OXY-TET 200 is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
Date of Approval: November 16, 1994

ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200; BIO-MYCIN® 200
Effect of Supplement: To add the subcutaneous route of administration to the label for cattle.
Date of Approval: May 22, 1996

ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200; BIO-MYCIN® 200
Effect of Supplement: This supplemental application establishes a 28 day withdrawal period for subcutaneous use in cattle and intramuscular use in swine (all approved routes of administration in cattle and swine).
Date of Approval: March 16, 1999

ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: oxytetracycline
Trade Name: OXY-TET® 200; BIO-MYCIN® 200
Effect of Supplement: This supplemental application provides for the use in lactating cattle.
Date of Approval: September 3, 2002

ANADA 200-023 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: gentamicin sulfate solution
Trade Name: Gentamicin Sulfate Solution 100 mg/mL
Indications for use: For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: August 4, 1995

ANADA 200-026 original approval
Sponsor: PennField Oil Company
Generic Name: oxytetracylcline hydrochloride
Trade Name: Pennox 343
Indications for use: Control of certain diseases caused by bacteria susceptible to oxytetracycline hydrochloride.
Date of Approval: March 13, 1997

ANADA 200-026 supplemental approval
Sponsor: PennField Oil Company
Generic Name: oxytetracylcline hydrochloride
Trade Name: Pennox 343
Effect of the Supplements: Revised withdrawal period (0-day) in turkeys & additional package size of 23.9 oz..
Date of Approval: February 5, 1999

ANADA 200-026 supplemental approval
Sponsor: PennField Oil Company
Generic Name: Oxytetracycline hydrochloride
Trade Name: Pennox™ 343
Effect of Supplement:Revised withdrawal period
(0-day) in swine
Date of Approval: April 10, 2002

ANADA 200-027 supplemental approval
Sponsor: Planalquimica Industrial Ltd
Generic Name: nicarbazin
Trade Name: Nicarmix (nicarbazin) 25%
Effect of Supplement: This supplement approves Nicarmix (nicarbazin) 25%, as manufactured by Planalquimica, as an equivalent to nicarbazin sold by Merck.
Date of Approval: May 30, 1995

ANADA 200-028 original approval
Sponsor: LAMBERT KAY
Generic Name:Pyrantel pamoate
Trade Name: Evict^®, Lassie^®, Vet's Own™
Indications for use: Evict® should be used to prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping and for removal of large roundworms and hookworms in dogs and puppies.
Date of Approval: March 28, 1996

ANADA 200-028 supplemental approval
Sponsor: Lambert-Kay
Generic Name: pyrantel pamoate
Trade Name: Evict® DS and Lassie® DS Liquid Wormer plus Vet's Own™ DS Canine Anthelmintic Suspension
Effect of Supplement: Provides for a double strength pyrantel pamoate suspension.
Date of Approval: June 4, 1997

ANADA 200-029 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: ketamine hydrochloride injection
Trade Name: Ketamine Hydrochloride Injection
Indications for use: Ketamine Hydrochloride Injection may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: August 16, 1995

ANADA 200-030 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: sulfadimethoxine 12.5% oral solution
Trade Name: Sulfadimethoxine 12.5% Oral Solution
Indications for use: BROILER AND REPLACEMENT CHICKENS: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. MEAT PRODUCING TURKEYS: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. FOR DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: December 31, 1992

ANADA 200-031 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: sulfadimethoxine
Trade Name: Sulfadimethoxine Antibacterial Soluble Powder
Indications for use: BROILER AND REPLACEMENT CHICKENS: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. MEAT PRODUCING TURKEYS: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. DAIRY CALVES, DAIRY HEIFERS AND BEEF: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: June 17, 1992

ANADA 200-033 original approval
Sponsor: Macleod Pharmaceuticals, Inc.
Generic Name: trimethoprim/sulfadiazine
Trade Name: Uniprim Powder
Indications for use: For control of bacterial infections of horses during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections and abscesses.
Date of Approval: June 11, 1993

ANADA 200-037 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: gentamicin 100 mg/mL solution
Trade Name: Gentamicin Sulfate Solution
Indications for use: For the control of bacterial infections of the uterus (metritis) in horses as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: February 8, 1993

ANADA 200-038 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: sulfadimethoxine
Trade Name: Sulfadimethoxine Injection 40%
Indications for use: Recommended in cattle for the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum , sensitive to sulfadimethoxine.
Date of Approval: May 25, 1993

ANADA 200-042 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name: ketamine hydrochloride injection, USP
Trade Name: Ketaject®
Indications for use: Ketaject® (ketamine hydrochloride injection. USP) may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: June 30, 1994

ANADA 200-046 original approval
Sponsor: Pfizer Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Soluble Powder 325 gm/lb
Indications for use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep, and goats.
Date of Approval: May 15, 1992

ANADA 200-046 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name:neomycin sulfate
Trade Name: Neomycin Sulfate Soluble Powder 325 g/lb
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 03, 1996

ANADA 200-049 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: tetracycline hydrochloride
Trade Name: TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER-324
Indications for use: For use in the control and treatment of the following conditions in swine, calves and poultry. SWINE: Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline. Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline. CHICKENS: Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli ; infectious synovitis caused by Mycoplasma synoviae susceptible to tetracycline. TURKEYS: Control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, corona viral enteritis) caused by complicating bacterial organisms susceptible to tetracycline.
Date of Approval: September 30, 1993

ANADA 200-050 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Indications for use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: February 15, 1995

ANADA 200-050 supplemental approval
Sponsor: Rhone-Merieux, Inc.
Generic Name:neomycin sulfate
Trade Name: Neomycin 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 03, 1996

ANADA 200-050 supplemental approval
Sponsor: Bimeda, Inc.
Generic Name:neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Effect of Supplement: This supplement provides for use of the addition of a new species, turkeys..
Date of Approval: July 10 2002

ANADA 200-055 original approval
Sponsor: Lloyd Incorporated
Generic Name: ketamine hydrochloride solution, USP
Trade Name: VetaKet ™
Indications for use: VetaKet^TM may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: August 3, 1998

ANADA 200-061 original approval
Sponsor: AgriLabs
Generic Name: flunixin meglumine
Trade Name: (to be established)
Indications for use: "Tradename" (flunixin meglumine) Solution is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
Date of Approval: September 11, 1996

ANADA 200-061 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: flunixin meglumine
Trade Name: Flunixin Meglumine Solution
Effect of Supplement: This supplement provides for the addition of a claim for intravenous use in beef cattle and nonlactating dairy cattle to the labeling of the approved product Flunixin Meglumine Solution. The exclusivity period protecting this claim for the pioneer product expired on May 6, 2001.
Date of Approval: July 29, 2004

ANADA 200-066 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: oxytetracycline hydrochloride
Trade Name: Agrimyn™-343 Soluble Powder
Indications for use: CHICKENS - INDICATIONS: Control of infectious synovitis caused by Mycoplasma synoviae . Dosage: 200-400 mg/gal. Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli . Dosage: 400-800-mg/gal. Control of fowl cholera caused by Pasteurella multocida . Dosage: 400-800-mg/gal. TURKEYS- INDICATIONS: Control of Hexamitiasis caused by Hexamita meleagridis . Dosage: 200-400 mg/gal. Control of infectious synovitis caused by Mycoplasma synoviae . Dosage: 400 mg/gal. Growing turkeys: Control of body weight complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) Dosage: 25 mg/lb. SWINE - INDICATIONS: FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE: Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis , susceptible to oxytetracycline. Bacterial pneumonia caused by Pasteurella multocida , susceptible to oxytetracycline. Dosage: 10 mg/lb body weight. FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona , susceptible to oxytetracycline. Dosage: 10 mg/lb body weight. GENERAL DIRECTIONS: Mix fresh solutions daily. Use as sole source of drinking water. Do not mix this product directly with milk or milk replacers. Administer one hour before or two hours after feeding milk or milk replacers. Consult a poultry diagnostic laboratory or poultry pathologist for diagnosis or advice on dosage for chickens or turkeys. As a generalization, 200 chickens will drink one gallon of water per day for each week of age. Turkeys will consume twice that amount. Administer up to 5 days to swine and 7 to 14 days for chickens and turkeys.
Date of Approval: July 15, 1994

NADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline HCl
Trade Name: AGRIMYCIN® 343 SOLUBLE POWDER
Effect of Supplement: Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. The ANADA sponsor is required to show that the generic product is bioequivalent to the pioneer. ANADA's for drug products for food-producing animals will generally be required to include bioequivalence and tissue residue studies. A tissue residue study will generally be required to accompany clinical end-point and pharmacologic end-point bioequivalence studies, and blood level bioequivalence studies that can not quantify the concentration of the drug in blood throughout the established withdrawal period. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, October 10, 2000).
Based upon the formulation characteristics of the generic product, AGRIMYCIN® 343 was granted a waiver from conducting an in vivo bioequivalence study and approved on July 15, 1994. The generic and pioneer products contain the same active and inactive ingredients and are soluble powders.
Date of Approval: October 04, 2001

ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Agrimycin® 166
Date of Approval: July 13, 2004

ANADA 200-068 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTETRACYCLINE Hydrochloride Injection
Indications for use: OXYTETRACYCLINE HCLINJECTABLE SOLUTION is for treatment of: Pasteurella spp. -- Bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; Escherichia coli -- Bacterial enteritis (scours); Spherophorous necrophorus -- Necrotic pododermatitis (foot rot), calf diphtheria; Actinobacillus lignierseii -- Wooden tongue; wound infection,acute metritis, and traumatic injury -- caused by oxytetracycline susceptible strains of streptococcal and staphylococcal bacteria.
Date of Approval: July 31, 1995

ANADA 200-069 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: gonadorelin diacetate tetrahydrate injection
Trade Name: Fertelin™ (Gonadorelin Diacetate Tetrahydrate) Sterile Solution
Indications for use: Fertelin (Gonadorelin) is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus.Historically, cyctic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotropin. Fertelin initiates release of endogenous LH to cause ovulation and luteinization
Date of Approval: August 01, 2002

ANADA 200-070 original approval
Sponsor: Abbott Laboratories
Generic Name: isoflurane, USP
Trade Name: IsoFlo™
Indications for use: IsoFlo (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.
Date of Approval: March 11, 1993

ANADA 200-071 original approval
Sponsor: Delmarva Laboratories, Incorporated
Generic Name: pentobarbital sodium and phenytoin sodium
Trade Name: Euthasol™
Indications for use: For use in dogs for humane, painless, and rapid euthanasia
Date of Approval: February 24, 1994

ANADA 200-073 original approval
Sponsor: American Veterinary Products, Inc.
Generic Name: ketamine hydrochloride injection, USP
Trade Name: Ketamine Hydrochloride Injection, USP
Indications for use: Ketamine hydrochloride injection, USP may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: July 21, 1994

ANADA 200-075 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium
Trade Name: Sacox®
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
Date of Approval: February 23, 1994

ANADA 200-075 original approval
Sponsor: Intervet Inc.
Generic Name: salinomycin sodium
Trade Name: Sacox®
Indications for use: 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; and to add quail to the label claim for the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae.
Date of Approval: November 8, 2002

ANADA 200-080 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: Salinomycin sodium, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Bambermycins
Trade Name: Sacox, 3-Nitro, Roxarsone, Flavomycin
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 , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: March 8, 1994

ANADA 200-081 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin methylene disalicylate
Trade Name: Sacox, 3-Nitro, BMD
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 , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for increased rate of weight gain.
Date of Approval: March 4, 1994

ANADA 200-082 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bacitracin methylene disalicylate
Trade Name: Sacox, BMD
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; and for rate of weight gain and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(iii)]. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(vi)]
Date of Approval: March 18, 1994

ANADA 200-083 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bambermycins
Trade Name: Sacox, Flavomycin
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 , and for improved feed efficiency.
Date of Approval: March 18, 1994

ANADA 200-086 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin zinc
Trade Name: Sacox, 3-Nitro, Albac
Indications for use: For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for improved feed efficiency in broiler chickens.
Date of Approval: March 28, 1994

ANADA 200-088 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: xylazine hydrochloride
Trade Name: Sedazine™
Indications for use: Sedazine (xylazine) should be used in horses and Cervidaewhen it is desirable to produce a state of sedation accompanied by a shorter period of analgesia. HORSES: Sedazine has been used successfully as follows: Diagnostic procedures -- oral and opthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations. Orthopedic procedures, such as application of casting materials and splints. Dental procedures. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations. To calm and facilitate handling of fractious animals. Therapeutic medication for sedation and relief of pain following injury or surgery. Major surgical procedures: when used as a preanesthetic to general anesthesia; when used in conjunction with local anesthetics. CERVIDAE : Sedazine may be used for the following: To calm and facilitate the handling of fractious animals. Diagnostic procedures. Minor surgical procedures. Therapeutic medication for sedation and relief of pain following injury or surgery. As a preanesthetic to local anesthesia. Sedazine at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.
Date of Approval: February 24, 1994

ANADA 200-089 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bacitracin zinc
Trade Name: Sacox, Baciferm
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 ; and for increased rate of weight gain.
Date of Approval: April 6, 1994

ANADA 200-090 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), lincomycin
Trade Name: Sacox, 3-Nitro, Lincomix
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 , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994

ANADA 200-091 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex/roxarsone
Trade Name: Sacox and 3-Nitro and Aureomycin
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 , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994

ANADA 200-092 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, virginiamycin
Trade Name: Sacox, Stafac
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 ; and for increased rate of weight gain and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(x)]. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain. [21 CFR § 558.550 (b)(1)(xi)]
Date of Approval: April 6, 1994

ANADA 200-093 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, lincomycin
Trade Name: Sacox Lincomix
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; and for improved feed efficiency.
Date of Approval: April 6, 1994

ANADA 200-094 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone, virginiamycin
Trade Name: Sacox 3-Nitro Stafac
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, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994

ANADA 200-095 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex
Trade Name: Sacox and Aureomycin
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 , and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994

ANADA 200-096 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/oxytetracycline
Trade Name: Sacox and Terramycin
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 , and as an aid in the reduction of mortality due to airsacculitis (air sac infection) caused by Escherichia coli infections sensitive to oxytetracycline.
Date of Approval: November 25, 1994

ANADA 200-097 original approval
Sponsor: Hoechst-Roussel Agri Vet Company
Generic Name: salinomycin sodium, roxarsone
Trade Name: Sacox 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; and for improved feed efficiency.
Date of Approval: April 6, 1994

ANADA 200-102 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: gentamicin sulfate solution
Trade Name: Gentaglyde™ Solution
Indications for use: For the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: May 19, 1994

ANADA 200-103 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: penicillin G potassium, USP
Trade Name: Penicillin G Potassium, USP
Indications for use: For the treatment of erysipelas in turkeys caused by Erysipelothrix rhusiopathiae .
Date of Approval: October 18, 1994

ANADA 200-106 original approval
Sponsor: I.D. Russell Company
Generic Name: penicillin G potassium
Trade Name: R-Pen
Indications for use: For treatment of erysipelas in turkeys (caused by Erysipelothrix rhusiopathiae).
Date of Approval: July 21, 1994

ANADA 200-108 original approval
Sponsor: Phoenix Pharmaceuticals, Inc.
Generic Name: Dexamethasone
Trade Name: Dexamethasone Solution
Indications for use: For the treatment of primary bovine ketosis and as an anti-inflammatory agent in dogs, cats, cattle, and horses.
Date of Approval: April 13, 1995

ANADA 200-109 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: vitamin E/selenium injection
Trade Name: Velenium™ (SELENIUM, VITAMIN E)
Indications for use: Velenium™ (SELENIUM, VITAMIN E) is recommended for the prevention and treatment of Selenium-Tocopherol Deficiency syndrome in weanling calves and breeding beef cattle.
Date of Approval: October 20, 1995

ANADA 200-113 original approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name: Biosol® Liquid
Indications for use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: June 28, 1993

ANADA 200-113 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: neomycin sulfate
Trade Name: Biosol® Liquid
Effect of Supplement: Changes withdrawal times and tolerance information.
Date of Approval: February 7, 1997

ANADA 200-115 original approval
Sponsor: Macleod Pharmaceuticals, Inc.
Generic Name: gentamicin sulfate solution
Trade Name: Gentamex™ 100
Indications for use: For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: July 21, 1995

ANADA 200-117 original approval
Sponsor: Cross Vetpharm Group Limited
Generic Name: oxytetracycline
Trade Name: Oxyshot LA
Indications for use: For the treatment of diseases caused by bacteria susceptible to oxytetracycline.
Data of Summary: April 13, 1995

ANADA 200-118 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Oral Solution
Indications for use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: November 29, 1994

ANADA 200-118 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Neomycin Sulfate
Trade Name: Neomycin Oral Solution
Effect of Supplement: To revise the withdrawal period to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats to be identical to pioneer product.
Date of Approval: July 14, 1998

ANADA 200-122 original approval
Sponsor: Wade Jones Company
Generic Name: Penicillin G Potassium
Trade Name: Solu-Pen
Indications for use: For the treatment of erysipelas in turkeys (casued by Erysipelothrix rhusiopathiae).
Date of Approval: April 17, 1995

ANADA 200-123 original approval
Sponsor:Phoenix Scientific, Inc.
Generic Name: oxytetracycline injection
Trade Name: Maxim 200
Indications for use: For use in the treatment of bacterial diseases in beef cattle, nonlactating dairy cattle and swine when caused by two oxytetracycline susceptible organisms.
Date of Approval: February 10, 1995

ANADA 200-123 supplemental approval
Sponsor:Phoenix Scientific, Inc.
Generic Name: oxytetracycline injection
Trade Name: Maxim 200
Effect of Supplement: Addition of subcutaneous route of administration for beef cattle, nonlactating dairy cattle, and preruminating (veal) calves.
Date of Approval: December 28, 2001

ANADA 200-123 supplemental approval
Sponsor:Phoenix Scientific, Inc.
Generic Name: Oxytetracycline Hydrochloride, USP
Trade Name: Maxim 200 Injection
Effect of Supplement: The supplement provides for use in lactating dairy cattle
Date of Approval: November 19, 2002

ANADA 200-124 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: flunixin meglumine solution
Trade Name: Flunixin Meglumine Solution
Indications for use: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.
Date of Approval: September 25, 1995

ANADA 200-124 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: flunixin meglumine injection
Trade Name: Flunixin Meglumine Solution
Effect of Supplement: The supplement provides revised labeling with the addition of a new species, cattle, to the previously approved generic product for horses only.
Date of Approval: November 01, 2001

ANADA 200-126 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: phenylbutazone, USP
Trade Name: PHENYLBUTAZONE 20% INJECTION
Indications for use: For relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: September 1, 1995

ANADA 200-126 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: phenylbutazone, USP
Trade Name: Phenylbutazone 20% Injection
Effect of Supplement: This supplemental application amends the ANADA to provide for the use of Phenylbutazone 20% Injection for the relief of inflammatory conditions associated with the musculoskeletal system in dogs. Phenylbutazone 20% Injection (ANADA 200-126) is currently approved for the same indication in horses.
Date of Approval: September 6, 1996

ANADA 200-127 original approval
Sponsor:The Upjohn Company
Generic Name:spectinomycin hydrochloride (dihydrochloride pentahydrate) sterile solution
Trade Name:undetermined TRADEMARK Injectable
Indications for use: As an aid in the control of Chronic Respiratory Disease (CRD) associated with Escherichia coli and as an aid in the control of airsacculitis associated with Mycoplasma meleagridis sensitive to spectinomycin in turkey poults. As an aid in the control of mortality and to lessen severity of infections caused by Mycoplasma synoviae, Salmonella typhimurium, Salmonella infantis, and Eschericia coli in chicks.
Date of Approval: May 9, 1996

ANADA 200-128 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline dihydrate injection
Trade Name: Agrimycin®-200
Indications for use: Beef cattle, dairy cattle, calves, including preruminating (veal) calves: indicated in the treatment of pneumonia and shipping fever complications associated with Pasteurella spp., and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; and wound infection and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.
Swine: indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows, it is indicated as an aid in the control of
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by
Escherichia coli.
Date of Approval: June 13, 2003

ANADA 200-129 original approval
Sponsor:Halocarbon Laboratories (Division of Halocarbon Products Corporation)
Generic Name: isoflurane, USP
Trade Name: isofluorane, USP
Indications for use: Isoflurane, USP is used for induction and maintenance of general anesthesia in dogs and horses.
Date of Approval: June 29, 1995

ANADA 200-130 supplemental approval
Sponsor: Alpharma
Generic Name: Neomycin sulfate
Trade Name: Neo-Sol® 50
Indications for use: This supplemental application provides for use in an additional species, growing turkeys.
Date of Approval: October 25, 2002

ANADA 200-134 original approval
Sponsor: Intervet Inc.
Generic Name: gonadorelin diacetate tetrahydrate
Trade Name: Fertagyl®
Indications for use: Fertagyl® is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus.
Historically, cystic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotropin. Fertagyl® initiates release of endogenous LH to cause ovulation and luteinization.
Date of Approval: June 17, 1996

ANADA 200-136 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: tetracycline hydrochloride-324
Trade Name: Tetracycline Hydrochloride Soluble Powder-324
Indications for use: For use in the control and treatment of certain diseases or infections caused by bacteria susceptible tootetracycline in swine, calves, chickens, and turkeys.
Date of Approval: December 17, 1996

ANADA 200-137 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name:Gentamicin sulfate solution
Trade Name: Gentamicin Sulfate Solution
Indications for use: For the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: November 13, 1996

ANADA 200-139 original approval
Sponsor: Chanelle Pharmaceutical Manufacturing Ltd.
Generic Name:xylazine hydrochloride
Trade Name: Chanazine® 100 mg/mL Injectable
Indications for use: Chanazine (xylazine) should be used in horses and Cervidae when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.
Date of Approval: May 16, 1995

ANADA 200-140 original approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: chlortetracycline, sulfathiazole, and penicillin
Trade Name: Aureozol^®
Indications for use: For use in pre-starter, starter, grower, and finisher feeds administered in complete feed to swine raised in confinement or on limited pasture to reduce the incidence of cervical abscesses; treat bacterial swine enteritis; maintain weight gains in the presence of atrophic rhinitis; and increase rate of weight gain and improved feed efficiency.
Date of Approval: December 2, 1997

ANADA 200-141 original approval
Sponsor: Inhalon Pharmaceuticals, Inc.
Generic Name: isoflurane, USP
Trade Name:Isoflurane, USP
Indications for use: For induction and maintenance of anesthesia in dogs and horses.
Date of Approval: July 26, 1994

ANADA 200-142 original approval
Sponsor:Fort Dodge Laboratories
Generic Name: flunixin meglumin
Trade Name: Flunixin Meglumine Solution
Indications for Use:"Tradename" (flunixin meglumine) solution is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
Date of Approval: September 25, 1995

ANADA 200-143 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone , bacitracin zinc
Trade Name:Sacox, 3-Nitro, Baciferm
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; and for increased rate of weight gain and improved feed efficiency.
Date of Approval: April 22, 1994

ANADA 200-144 original approval
Sponsor: Rhone Merieux, Canada, Inc.
Generic Name:oxytetracycline hydrochloride
Trade Name: Undetermined
Indications for use: Oxytetracycline HCL soluble powder is for control of Mycoplasma synoviae, M. gallisepticum, Escherichia coli, and Pasteurella multocida in chickens and Hexamita meleagridis, Mycoplasma synoviae, transmissible eneritis, and coronaviral enteritis in turkeys; and control and treatment of Escherichia coli, Salmonella choleraesuis, Pasteurella multiocida, and Leptospira pomona in swine.
Date of Approval: June 26, 1995

ANADA 200-144 supplemental approval
Sponsor: Cross Vetpharm Group Limited.
Generic Name: Oxytetracycline HCl
Trade Name: TETROXY® HCA-1772
Indications for use: FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE – Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona, susceptible to oxytetracycline.
Date of Approval: APRIL 21, 2003

ANADA 200-146 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTETRACYCLINE HCL SOLUBLE POWDER
Indications for use: It is for control control and treatment of a variety of infectious diseases caused by bacteria susceptible to oxytetracycline in chickens turkeys swine, cattle, and sheep.
Date of Approval: April 22, 1994

ANADA 200-146 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Oxytetracycline HCl Soluble Powder
Effect of Supplement: This supplemental application provides for the addition of the 2.26 kg (5 lb) bucket with a scoop. The scoop has also been added to the 907.2 g (2 lb) bucket. Revised labeling provides the statement warning against use in calves to be processed for veal and female dairy cattle 20 months of age or older.
Date of Approval: August 15, 1996

ANADA 200-147 original approval
Sponsor: Sanofi Animal Health, Inc.