FOI Documents 200-000 - 200-999
Listed with Abstracts from the Summaries
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 injection
Trade Name: 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 Supplement: 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: VetaKetTM 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
ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline HCl
Trade Name: AGRIMYCIN® 343 SOLUBLE POWDER
Effect of Supplement: Revised withdrawal period for turkeys and swine.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. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. 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, April 1990).Based upon the formulation characteristics of the genetic product, Agri Laboratories Ltd. was granted a waiver from conducting an in vivo bioequivalence study for Oxytetracycline HCl Soluble Powder. The genetic and pioneer products contain the same active ingredient and are water soluble powders administered as oral solutions. The genetic product contains no inactive ingredients that may significantly affect the absorption of the active ingredient.
Date of Approval: October 04, 2001
ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Agrimycin® 166
Effect of Supplement: The supplement provides for approval of an additional packet size, 9.87 oz [280 g], a different trade name, an alternate concentration of active ingredient and a change in the inactive ingredients in the finished dosage form.
Date of Approval: June 30, 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 supplemental 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; and for increased rate of weight gain and improved feed efficiency.
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 Solution
Trade Name: Dexamethasone Solution
Indications for Use: 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 injection
Trade Name: Oxyshot™ LA
Indications for Use: For the treatment of diseases caused by bacteria susceptible to oxytetracycline.
Date of Approval: 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 200-124 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Flunixin meglumine
Trade Name: Flunixin Meglumine Injection
Effect of Supplement: This supplement provides the addition of lactating dairy cattle to the existing claim allowing for the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia. The addition of lactating dairy cattle to the pioneer labeling was approved on August 19, 2004, and was not protected by exclusivity.
Date of Approval: July 18, 2005
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: isoflurane, 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 Inc.
Generic Name: Neomycin sulfate
Trade Name: Neo-Sol® 50
Effect of Supplement: 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 injection
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 to otetracycline 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 meglumine
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 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 200-144 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 200-146 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 200-146 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 200-147 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Gentamicin Sulfate Injection
Indications for Use: GENTAMICIN SULFATE INJECTION is indicated for use in the prevention of early motality in day-old chickens caused by Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.
Date of Approval: April 10, 1995
ANADA 200-147 supplemental approval
Sponsor: Merial Ltd.
Generic Name: gentamicin sulfate solution
Trade Name: Genta-Ject ™
Effect of Supplement: This supplemental application provides for the addition of a new species (turkeys).
Date of Approval: October 30, 1998
ANADA 200-153 original approval
Sponsor: Rhone Merieux, Inc.
Generic Name: neomycin sulfate
Trade Name: NEO 200 Oral Solution
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 8, 1996
ANADA 200-154 original approval
Sponsor: Pennfield Oil Co
Generic Name: oxytetracycline injection
Trade Name: Oxytetracycline 200
Indications for Use: For use in the treatment of infectious diseases in beef cattle, nonlactating dairy cattle and swine when due to oxytetracycline susceptible organisms.
Date of Approval: May 8, 1996
ANADA 200-154 supplemental approval
Sponsor: Pennfield Oil Co
Generic Name: Oxytetracycline Hydrochloride, USP
Trade Name: Pennox™ 200 Injection
Effect of Supplement: The supplement provides for the addition of the subcutaneous administration of oxytetracycline injectable solution in beef cattle, non-lactating dairy cattle, and calves, including pre-ruminating (veal) calves.
Date of Approval: January 12, 2001
ANADA 200-154 supplemental approval
Sponsor: Pennfield Oil Co
Generic Name: Oxytetracycline Hydrochloride, USP
Trade Name: Pennox 200 Injection
Effect of Supplement: The supplement provides for the use in lactating diary cattle.
Date of Approval: June 13, 2002
ANADA 200-162 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: tripelennamine hydrochloride
Trade Name: Tripelennamine Hydrochloride Injection
Indications for Use: For use in conditions in which antihistaminic therapy may be expected to lead to the alleviation of some signs of disease in cattle and horses.
Date of Approval: March 28, 1996
ANADA 200-164 original approval
Sponsor: Planalquimica Industrial Ltd.
Generic Name: nicarbazin, bacitracin methylene disalicylate
Trade Name: Nicarmix 25, BMD
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis in broiler chickens and for increased rate of weight gain and improved feed efficiency.
Date of Approval: November 29, 1995
ANADA 200-165 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: sulfadimethoxine 12.5% oral solution
Trade Name: SDM Sulfadimethoxine 12.5% Oral Solution
Indications for Use: For Broiler and replacement chicken: Coccidiosis, fowl cholera, and coryza; Meat producing turkey: Coccidiosis and fowl cholera; dairy calves and heifers, and beef cattle: Shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: December 4, 1996
ANADA 200-167 original approval
Sponsor: Hoffmann-La Roche Inc. (formerly American Cyanamid)
Generic Name: chlortetracycline, sulfathiazole, and penicillin
Trade Name: Aureozol® 500 Granular
Indications for Use: Administer to swine in a complete feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain and improved feed efficiency in pigs from 10 pounds of body weight to 6 weeks post-weaning; and increased rate of weight gain in pigs from 6 to 16 weeks post-weaning. For swine raised in confinement (dry lot) or on limited pasture.
Date of Approval: December 1, 1997
ANADA 200-168 original approval
Sponsor: Equi Aid Products Inc.
Generic Name: pyrantel tartrate
Trade Name: CW 48 (Type A medicated article)
Indications for Use: For use in horses for prevention and/or control of certain strongyle, pinworm, and ascarid infections.
Date of Approval: July 24, 1997
ANADA 200-170 original approval
Sponsor: Planalquimica Industrial Ltda.
Generic Name: Nicarbazin, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Lincomycin hydrochloride monohydrate
Trade Name: Nicarmix 25®, 3-Nitro®, Lincomix®
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,and E. brunetti) coccidiosis and for increased rate of weight gain in broiler chickens.
Date of Approval: March 5, 1996
ANADA 200-171 original approval
Sponsor: Planalquimica Industrial Ltda.
Generic Name: Nicarbazin, Lincomycin hydrochloride monohydrate
Trade Name: Nicarmix 25®, Lincomix®
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella ) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis and for increased rate of gain in broiler chickens.
Date of Approval: March 5, 1996
ANADA 200-172 original approval
Sponsor: Planalquimica Industrial Ltd.
Generic Name: Nicarbazin, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
Trade Name: Nicarmix 25®, 3-Nitro®
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella ) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis and for increased rate of weight gain in broiler chickens.
Date of Approval: March 5, 1996
ANADA 200-174 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: gentamicin sulfate
Trade Name: Gentamicin Sulfate Pig Pump Oral Solution
Indications for Use: For treatment of colibacillosis in neonatal pigs 1-3 days of age.
Date of Approval: April 10, 1997
ANADA 200-176 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Praziquantel
Trade Name: Prazitech™ Injection
Indications for Use: For the removal of the following cestodes: Dogs - Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and Echinococcus multilocularis. Cats - Taenia taeniaeformis and Dipylidium caninum.
Date of Approval: October 16, 2002
ANADA 200-177 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: sulfadimethoxine injection 40%
Trade Name: Sulfadimethoxine
Indications for Use: For 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 diptheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.
Date of Approval: March 13, 1997
ANADA 200-178 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: amikacin sulfate, USP
Trade Name: Amikacin Sulfate Injection
Indications for Use: For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus spp. and sking and soft tissue infections caused by susceptible strains of Pseudommonas sp. and Escherichia coli.
Date of Approval: March 14, 1997
ANADA 200-180 original approval
Sponsor: G.C. Hanford Mfg. Co.
Generic Name: Ampicillin Trihydrate
Trade Name: Ampicillin Trihydrate
Indications for Use: For the treatment of respiratory tract, urinary tract, gastrointestinal infections and skin, soft-tissue and post-surgical infection in dogs and cats. Respiratory tract infections in cattle and calves including non-ruminating (veal calves).
Date of Approval: April 24, 1998
ANADA 200-181 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: amikacin sulfate solution, 250 mg/mL
Trade Name: Amikacin Sulfate Solution
Indications for Use: For the treatment of uterine infections (endometritis, metritis, and pyometra) in mares, when caused by susceptible organisms including E. coli, Pseudomonas sp., and Klebsiella sp.
Date of Approval: March 18, 1997
ANADA 200-183 original approval
Sponsor: Med-Pharmex Inc.
Generic Name: Gentamicin sulfate and betamethasone valerate otic solution
Trade Name: Gentavet® Otic Solution
Indications for Use: Gentavet Otic Solution is indicated for the treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.
Date of Approval: July 31, 1995
ANADA 200-184 original approval
Sponsor: Chanelle Pharmaceutical Manufacturing Ltd.
Generic Name: Xylazine hydrochloride, 20 mg/mL
Trade Name: Chanazine® 20 mg/mL
Indications for Use: Chanazine (xylazine) should be used in dogs and cats when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.
Date of Approval: July 12, 1996
ANADA 200-185 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: gentamicin sulfate soluble powder
Trade Name: Gen-gard™ Soluble Powder
Indications for Use: For the control and treatment of colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicin, and the control and treatment of swine dysentery associated with Treponema hyodysenteriae.
Date of Approval: April 30, 1997
ANADA 200-187 original approval
Sponsor: Marsam Pharmaceuticals, Inc.
Generic Name: Isoflurane, USP
Trade Name: Isoflurane, USP
Indications for Use: IsoFlo (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.
Date of Approval: February 11, 1998
ANADA 200-188 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: gentamicin sulfate and betamethasone valerate topical spray
Trade Name: Betagen™ Topical Spray
Indications for Use: For the treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin.
Date of Approval: January 29, 1997
ANADA 200-189 original approval
Sponsor: I.D. Russell Company Laboratories
Generic Name: lincomycin hydrochloride
Trade Name: Lincomycin Soluble
Indications for Use: For treatment of dysentery (bloody scours) in swine and for the control in broiler chickens of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.
Date of Approval: November 7, 1997
ANADA 200-189 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: lincomycin hydrochloride
Trade Name: Lincomycin Soluble
Effect of Supplement: Removal of the withdrawal period in swine. Removal of the weight restriction in swine.
Date of Approval: September 19, 2002
ANADA 200-191 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: gentamicin sulfate
Trade Name: Gentasol (gentamicin sulfate solution)
Indications for Use: For the reduction or elimination of the following organisms from turkey hatching eggs: Arizon hinshawii (paracolon), Salmonella st. paul, Mycoplasma meleagridis.
Date of Approval: March 24, 1997
ANADA 200-192 original approval
Sponsor: Phoenix Scientific, Inc
Generic Name: sulfadimethoxine B.P.
Trade Name: Sulfadimethoxine 12.5% Oral Solution
Indications for Use: Dairy Calves, Dairy Heifers and Beef Cattle- Use for the treatment of shipping fever complex, and bacterial pneumonia associated with Pasteurella Spp. sensitive to sulfadimethoxine; and calf diptheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Date of Approval: March 24, 1997
ANADA 200-193 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: clindamycin hydrochloride, USP
Trade Name: Clindamycin hydrochloride oral liquid
Indications for Use: For therapy of wounds, abscesses, dental infections, and osteomyelitis.
Date of Approval: August 1, 1997
ANADA 200-193 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin Hydrochloride, USP
Trade Name: Clindamycin Hydrochloride Oral Liquid
Effect of Supplement: provides for the addition of feline claims to the previous approved label for use in canine only.
Date of Approval: December 27, 2000
ANADA 200-193 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clindamycin Hydrochloride Oral Liquid
Effect of Supplement: The supplement provides for approval of a dose range and revised indications for use of Clindamycin Hydrochloride Oral Liquid in dogs and cats which was approved for the pioneer product under NADA 135-940 (67 FR 54954, Aug. 27, 2002) with no exclusivity period. The expanded range was changed from a point dose of 2.5 mg/lb. in dogs to an expanded range of 2.5 to 15 mg/lb. The change in cats was from a range of 5.0 to 10.0 mg/lb. to a range of 5.0 to 15.0 mg/lb. The revised indications provides for a change in the words ‘soft tissues infections’ to ‘skin infections’ for dogs and cats.
Date of Approval: April 21, 2004
ANADA 200-196 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: miconazole nitrate lotion/spray 1%
Trade Name: Miconosol
Indications for Use: For treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.
Date of Approval: August 4, 1997
ANADA 200-197 original approval
Sponsor: Contemporary Products, Inc.
Generic Name: streptomycin sulfate 25% solution
Trade Name: Streptomycin Oral Solution
Indications for Use: Chickens: For the treatment of non-specific infectious enteritis caused by organisms susceptible to streptomycin sulfate. Swine and Calves: For the treatment of bacterial enteritis caused by Escherichia coli and Salmonella spp. susceptible to streptomycin sulfate.
Date of Approval: August 3, 1998
ANADA 200-200 original approval
Sponsor: Halocarbon Products Corporation
Generic Name: halothane, USP
Trade Name: Halothane, USP
Indications for Use: For induction and maintenance of anesthesia in dogs, cats, and other non-food animals.
Date of Approval: April 10, 1997
ANADA 200-202 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin
Trade Name: Phoenectin™ Liquid for Horses
Indications for Use: For the treatment and control of large strongyles (adult) (Strongylus equinus), (adult andarterial larval stages) (Strongylus vulgaris), (adult and migrating tissue stages)(Strongylus endentatus) (adult) (Triodontophorus spp.); small strongyles (adult and fourth stagelarvae) (Cyathostomum spp. Cylicocyclus spp., Cylicodontophorus spp.Cylicostephanus spp.); pinworms (adult and fourth stagelarvae) (Oxyuris equi); ascarids (third- and fourth-stagelarvae and adults) (Parascaris equorum); hairworms (adult) (Trichostongylusaxei); large mouth stomach worms (adult) (Habronemamuscae); stomach bots (oral and gastric stages) (Gastrophilus spp.); lungworms (adults and fourth stage larvae) (Dictyocaulusarnfieldi); intestinal threadworms (adults) (Strongyloides westeri); summer sores caused by Habronema and Draschia spp. cutaneous third stage larvae; and dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).
Date of Approval: June 5, 1998
ANADA 200-203 original approval
Sponsor: Alpharma, Inc.
Generic Name: carbarsone, bacitracin zinc
Trade Name: Carb-O-Sep®, Albac®
Indications for Use: As an aid in preventing blackhead and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-204 original approval
Sponsor: Alpharma, Inc.
Generic Name: salinomycin, bacitracin zinc
Trade Name: Bio-Cox®, Albac®
Indications for Use: For the prevention of coccidiosis 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: Sept. 22, 1997
ANADA 200-205 original approval
Sponsor: Alpharma, Inc.
Generic Name: amprolium, ethopabate, bacitracin zinc
Trade Name: Amprol HI-E®, Albac®
Indications for Use: (1) To aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur in broiler chickens and replacement chickens where immunity to coccidiosis is not desired and for increased rate of weight gain in broiler chickens raised in floor pens. (2) To aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur, and for improved feed efficiency in broiler chickens.
Date of Approval: Sept. 22, 1997
ANADA 200-206 original approval
Sponsor: Alpharma, Inc.
Generic Name: decoquinate, bacitracin zinc, roxarsone
Trade Name: Deccox®; Albac®; 3-Nitro®
Indications for Use: To prevent coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-207 original approval
Sponsor: Alpharma, Inc.
Generic Name: clopidol, bacitracin zinc, roxarsone
Trade Name: Coyden 25®, Albac®, 3-Nitro®
Indications for Use: To aid in preventing coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
Date of Approval: Sept. 22, 1997
ANADA 200-208 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid, Roxarsone, Bacitracin zinc
Trade Name: AVATEC, 3-NITRO, ALBAC
Indications for Use: 1) For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the reduction of lesions due to E. tenella; and for increased rate of weight gain in broiler chickens only. 2) For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the reduction of lesions due to E. tenella; and for improved feed efficiency in broiler chickens only.
Date of Approval: June 24, 2002
ANADA 200-209 original approval
Sponsor: Alpharma, Inc.
Generic Name: salinomycin, bacitracin zinc, roxarsone
Trade Name: Sacox®, Albac®, 3-Nitro®
Indications for Use: To prevent coccidiosis caused by susceptible organisms and for increases rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-210 original approval
Sponsor: Alpharma, Inc
Generic Name: salinomycin, bacitracin zinc
Trade Name: Sacox®, Albac®
Indications for Use: For the prevention of coccidiosis 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: Sept. 22, 1997
ANADA 200-211 original approval
Sponsor: Alpharma, Inc.
Generic Name: monensin, bacitracin zinc, roxarsone
Trade Name: Coban®, Albac®, 3-Nitro®
Indications for Use: 1) To prevent coccidiosis caused by Eimeria tenella, E. necatrix, E. acervuolina, E. brunetti, E. mivati and E. maxima and for increased rate of weight gain; 2) To prevent coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency and improved pigmentation by enhancing carotenoid and xanthophyll use.
Date of Approval: Sept. 22, 1997
ANADA 200-212 original approval
Sponsor: Alpharma, Inc.
Generic Name: robenidine hydrochloride, bacitracin zinc
Trade Name: Robenz®, Albac®
Indications for Use: To aid in preventing coccidiosis caused by susceptible organisms; and, in the presence of 4 to 30 g/ton bacitractin zinc, for increased rate of weight gain; and, in the presence of 27 to 50 g/ton bacitracin zinc, for improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-213 original approval
Sponsor: Alpharma, Inc.
Generic Name: decoquinate, bacitracin zinc
Trade Name: Deccox®, Albac®
Indications for Use: To aid in preventing coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-214 original approval
Sponsor: ALPHARMA, Inc.
Generic Name: amprolium, ethopabate, bacitracin zinc, roxarsone
Trade Name: Amprol HI-E®, Albac®, 3-Nitro®
Indications for Use: 1) To aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur and for improved feed efficiency in broiler chickens; 2) to aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur and for improved feed efficiency and improved pigmentation in broiler chickens.
Date of Approval: Sept. 22, 1997
ANADA 200-215 original approval
Sponsor: Alpharma, Inc.
Generic Name: salinomycin, bacitracin zinc, roxarsone
Trade Name: Bio-Cox®, Albac®, 3-Nitro®
Indications for Use: To prevent coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-217 original approval
Sponsor: Alpharma Inc.
Generic Name: amprolium, ethopabate, bacitracin zinc, roxarsone
Trade Name: Amprol Hi-E®, Albac®, 3-Nitro®
Indications for Use: To aid in preventing coccidiosis where severe exposure from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur, and for increased rate of weight gain in broiler chickens raised in floor pens.
Date of Approval: September 22, 1997
ANADA 200-218 original approval
Sponsor: Alpharma, Inc.
Generic Name: clopidol, bacitracin zinc
Trade Name: Coyden 25®, Albac®
Indications for Use: To aid in preventing coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati and E. brunetti and for increased rate of weight gain and improved feed efficiency.
Date of Approval: Sept. 22, 1997
ANADA 200-219 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Phoenectin™ Pour-On for Cattle
Indications for Use: For the control of the following parasites: gastrointestinal roundworms (Ostertagia ostertagi, adult and fourth stage larvae including inhibited stage; Haemonchus placei, adults and fourth stage larvae; Trichostrongylus axei, adults and fourth stage larvae; T. colubriformis, adults and fourth stage larvae; Cooperia spp., adults and fourth stage larvae; Strongyloides papillosus, adults; Oesophagostomum radiatum, adults and fourth stage larvae; O. venulosum, adults only; Trichuris spp., adults: lungworms (Dictyocaulus viviparus, adults and fourth stage larvae); cattle grubs (Hypoderma bovis, H. lineatum, parasitic stages); mites (Sarcoptes scabei var. bovis, Chorioptes bovis); lice (Linognathus vituli, Haematopinus eurysternus, Damalina bovis, Solenoptes capillatus); and horn flies (Haematobia irritans).
Date of Approval: July 6, 1998
ANADA 200-219 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Phoenectin™ Pour-On for Cattle
Indications for Use: Ivermectin Pour-On applied at the recommended dose level of 500mcg/kg is indicated for the effective control and treatment of these parasites: Gastrointestinal Roundworms: Ostertagia ostertagi (adults and L4) (including inhibited stage), Haemonchus placei (adults and L4), Trichostrongylus axei (adults and L4), T. colubriformis (adults and L4), Cooperia spp. adults and L4), Strongyloides papillosus (adults), Oesophagostomum radiatum (adults and L4), Trichuris spp. (adults). Lungworms: Dictyocaulus viviparus (adults and L4). Cattle Grubs: (parasitic stages): Hypoderma bovis, H. lineatum. Mites: Sarcoptes scabiei var. bovis. Lice: Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenopotes capillatus. Horn Flies: Haematobia irritants. Phoenectin™ Pour-On has been proved to effectively control infections and to protect cattle from re-infection with Ostertagia ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
Date of Approval: May 16, 2001
ANADA 200-221 original approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate and estradiol
Trade Name: Component™ TE-S
Indications for Use: For increased rate of weight gain and improved feed efficiency in feedlot steers.
Date of Approval: March 20, 1997
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate, estradiol, and Tylosin Tartrate
Trade Name: Component®TE-S with Tylan®
Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® TE-S with Tylan®
Date of Approval: July 20, 1999
ANADA 200-221 original approval
Sponsor: Ivy Laboratories, Inc., Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: Component® TE-G
Indications for Use: For increased rate of weight gain in pasture cattle (slaughter, stocker, and feeder steers and heifers).
Date of Approval: March 6, 2000
ANADA 200-221 supplemental approval
Sponsor: Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate, Estradiol, and Tylosin Tartrate
Trade Name: Component® TE-G with Tylan®
Effect of Supplement: This supplement provides for adding tylosin tartrate pellet as a local antibacterial to Component® TE-G
Date of Approval: September 18, 2000
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Inc., Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: Component® TE-G
Indications for Use: The supplement provides for the use of a generic copy of Intervet, Inc.’s REVALOR-IS, a 4-pellet ear implant containing 80 mg trenbolone acetate and 16 mg estradiol.
Date of Approval: September 3, 2003
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Inc., Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone acetate, estradiol, tylosin tartrate
Trade Name: Component® TE-IS with Tylan®
Indications for Use: For increased rate of weight gain and improved feed efficiency. The supplement provides for the use of a generic copy of Intervet, Inc.’s REVALOR-IS, a 4-pellet ear implant containing 80 mg trenbolone acetate and 16 mg estradiol.
Date of Approval: February 13, 2004
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-S, COMPONENT TE-IS, COMPONENT TE-G, COMPONENT TE-S with TYLAN, COMPONENT TE-IS with TYLAN, COMPONENT TE-G with TYLAN
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004
ANADA 200-223 original approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin zinc
Trade Name: Albac®50
Indications for Use: For improved feed efficiency in growing-finishing feedlot steers; For increased rate of weight gain and improved feed efficiency in growing-finishing feedlot heifers.
Date of Approval: August 20, 1997
ANADA 200-224 original approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate
Trade Name: Component™ T-S; Component™T-H
Indications for Use: For improved feed efficiency in growing-finishing feedlot steers; for increased rate of weight gain and improved feed efficiency in growing-finishing feedlot heifers.
Date of Approval: April 30, 1997
ANADA 200-224 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate and Tylosin Tartrate
Trade Name: 1) Component® T-S with Tylan® 2) Component®T-H with Tylan®
Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® T-S and Component® T-H
Date of Approval: July 20, 1999
ANADA 200-224 supplemental approval
Sponsor: Ivy Laboratories
Generic Name: Trenbolone Acetate, Trenbolone Acetate with Tylosin
Trade Name: COMPONENT T-H, COMPONENT T-S, COMPONENT T-H with TYLAN, and COMPONENT T-S with TYLAN
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 22, 2004
ANADA 200-225 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name:
