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U.S. Department of Health and Human Services

Animal & Veterinary

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137-601 to 140-530

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

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

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

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 Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.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

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

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

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

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

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

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

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

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

NADA 138-612 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Trenbolone Acetate
Trade Name: FINAPLIX-H
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

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

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

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

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

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

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

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

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

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

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

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

NADA 138-870 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin and tylosin phosphate
Trade Name: MGA plus Rumensin plus Tylan
Effect of Supplement: This supplement provides for an increase in the upper dose limit of monensin to 480 mg/hd/day based upon the December 1, 2006, approval (N-095735-C-0297) for monensin, and to update the name of the tylosin targeted bacteria to Arcanobacterium pyogenes based on the November 7, 2006, approval (N-012491-C-0318) for tylosin phosphate, for increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in heifers fed in confinement for slaughter.
Date of Approval: October 19, 2009

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

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

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

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

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

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

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

NADA 138-935 supplemental approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline
Trade Name: PENNCHLOR Type A Medicated Article
Effect of Supplement: To change the withdrawal time for cattle for PENNCHLOR Type A Medicated Article from one day to zero days.
Date of Approval: February 28, 2006

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

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

NADA 138-952 original approval
Sponsor: Elanco Products Company
Generic Name: Narasin and Nicarbazin Type A Article
Trade Name: MAXIBAN®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima .
Date of Approval: January 18, 1989

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

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

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

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

NADA 138-992 supplemental approval
Sponsor: The Upjohn Company
Generic Name: Melengestrol acetate, Lasalocid, Tylosin
Trade Name: MGA® 100/200 Premix, MGA® 500 Liquid Premix, BOVATEC®, TYLAN®
Effect of Supplement: This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination either with lasalocid or with lasalocid and tylosin.
Date of Approval: June 29, 1994

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

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

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

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

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

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

NADA 138-792; 138-870; 138-995; 139-192 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, monensin, tylosin
Trade Name: MGA;100/200 Premix, MGA;500 Liquid Premix, RUMENSIN;, TYLAN;
Effect of Supplement: This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination with tylosin or with tylosin and monensin. Previous approvals have required a 48 hour pre-slaughter drug withdrawal for heifers fed melengestrol acetate when fed in combination with either tylosin or monensin and tylosin.
Date of Approval: June 29, 1994

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

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

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

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

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

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

NADA 139-237 supplemental approval
Sponsor: Zoetis Inc.
Generic Name: gonadorelin hydrochloride
Trade Name: Factrel Injection
Indications for Use: This supplement provides for addition of a new indication for use with LUTALYSE (dinoprost tromethamine) Sterile Solution to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows.
Date of Approval: June 28, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NADA 140-011 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin hydrogen fumarate + chlortetracycline (equivalent to chlortetracycline hydrochloride)
Trade Name: Denagard® 10; chlortetracycline premixes
Indications for Use: For the control of swine dysentery associated with Serpulina hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida sensitive to chlortetracycline.
Date of Approval: August 20, 1996

NADA 140-014 original approval
Sponsor: Ausa International Inc.
Generic Name: Follicle stimulating hormone (FSH)
Trade Name: SUPER-OV®
Indications for Use: SUPER-OV® is indicated for the induction of superovulation in cows for procedures requiring the production of multiple ova at a single estrus. SUPER-OV® is effective only in cows that are not pregnant and have a normal corpus luteum, i.e. those cows that are cycling normally.
Date of Approval: August 13, 1993

NADA 140-269 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: ketoprofen
Trade Name: Ketofen™
Indications for Use: Ketofen(TM) is indicated for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Date of Approval: September 26, 1990

NADA 140-270 original approval
Sponsor: Medico Industries, Inc.
Generic Name: sulfamethazine
Trade Name: Sulfamethazine Sustained Release Bolus
Indications for Use: Sulfamethazine Sustained Release Bolus is indicated for the treatment of the following diseases in beef cattle and non-lactating dairy cattle: Bovine respiratory disease complex (shipping fever complex) associated with Pasteurella spp.; bacterial pneumonia associated with Pasteurella spp.; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; colibacillosis (bacterial scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. zurnii; acute mastitis and metritis caused by Streptococcus spp.
Date of Approval: August 25, 1986

NADA 140-288 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid, tylosin
Trade Name: MGA®100/200 Premix, MGA®500 Liquid Premix, BOVATEC®, TYLAN®
Effect of Supplement: This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination either with lasalocid or with lasalocid and tylosin.
Date of Approval: June 29, 1994

NADA 140-338 original approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Indications for Use: Naxcel Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia).
Date of Approval: January 25, 1988

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Effect of Supplement: This supplemental application provides for a change in the approved dosage of 0.5 mg/lb body weight to a range of 0.5 mg to 1.0 mg ceftiofur sodium/lb of body weight.
Date of Approval: April 5, 1990

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCELR® Sterile Powder
Effect of Supplement: Provides for the use of ceftiofur sodium (NAXCEL Sterile Powder) in lactating dairy cattle, a new class of animal, for the same indications approved in the parent NADA.
Date of Approval: March 15, 1991

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: This supplement provides for an additional species, swine, to be added to the previously approved product, NAXCEL®
Date of Approval: August 4, 1992

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: The supplement provides data in support of a request for approval of Naxcel ® Sterile Powder for an additional species (equine). The issue of the Freedom of Information (FOI) Summary should be considered an extension of previously approved version describing data in support of Naxcelreg., NADA 140-338, approved as a treatment for respiratory disease in cattle January 25, 1988.
Date of Approval: July 13, 1994

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: Provides for the use of ceftiofur sodium (NAXCEL® Sterile Powder) in cattle for a new indication.
Date of Approval: August 24, 1995

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: Provides for an additional species, day-old turkey poults, to be added to the previously approved product, NAXCEL® Sterile Powder; also provides for revision of the chick indication.
Date of Approval: May 21, 1996

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Effect of Supplement: The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL Sterile Powder) for the treatment of bacterial pneumonia in sheep.
Date of Approval: October 25, 1996

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Effect of Supplement: The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL? Sterile Powder) for the treatment of bacterial pneumonia in goats to be added to the previously approved NAXCEL label.
Date of Approval: March 7, 2001

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® brand of ceftiofur sodium sterile powder.
Effect of Supplement: Provides for the use of a subcutaneous (SC) route of administration for NAXCEL® Sterile Powder in cattle.
Date of Approval: May 29, 2001

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: This supplement provides four specific changes to the product insert, 1) revision of the “clinical microbiology” section to update the MIC table using the new MIC data for ceftiofur, 2) the addition of a table listing acceptable quality control ranges for ceftiofur, 3) the addition of the latest National Committee for Clinical Laboratory Standards (NCCLS) reference at the end of the insert, and 4) clarification of the statement under “Storage Conditions” dealing with the storage of reconstituted Naxcel via freezing.
Date of Approval: December 31, 2003

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: This supplement updates survey microbiological data and adds the National Committee for Clinical Laboratory Standards’ (NCCLS) interpretive criteria for equine isolates to the NAXCEL Sterile Powder package insert.
Date of Approval: February 27, 2004

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: For the treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis type 2.
Date of Approval: June 18, 2004

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: To establish a 4-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 140-339 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: Nicarbazin, bambermycins
Trade Name: Nicarb®, Flavomycin®
Indications for Use: As an aid in preventing outbreaks of cecal coccidiosis caused by Eimeria tenella, intestinal coccidiosis caused by E. acervulina, E. maxima, E. nectarix, and E. brunetti,, increased rate of weight gain and improved feed efficiency.
Date of Approval: August 6, 1999

NADA 140-340 original approval
Sponsor: Roussel-Uclaf
Generic Name: lincomycin, halofuginone hydrobromide
Trade Name: Lincomix®, Stenorol®
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 21, 1989

NADA 140-439 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: EQVALAN Liquid
Indications for Use: For treatment and control of the following parasites or parasitic conditions in horses: bots, large mouth stomach worms, neck threadworms, pinworms, ascarids, lungworms, intestinal threadworms, small strongyles large strongyles, summer sores, and dermatitis caused by neck threadworm microfilariae.
Date of Approval: July 1, 1987

NADA 140-439 supplemental approval
Sponsor: Merial Ltd.
Generic Name: ivermectin
Trade Name: EQVALAN Liquid For Horses
Effect of Supplement: This supplement amends the EQVALAN (ivermectin) Oral Liquid For Horses labeling to add four species of internal parasites and to reflect a change in the Indications section which separates the listing of adult small strongyle species from their related fourth-stage larvae. Specifically, the supplement provides for the use of ivermectin oral liquid for the treatment and control of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus spp. including Coronocyclus coronatus and Coronocyclus labratus. In addition, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from their related fourth-stage larvae.
Date of Approval: August 9, 2004

NADA 140-441 original approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Indications for Use: For the treatment of dermal infections, respiratory infections, and urinary cystitis caused by susceptible strains of bacteria in dogs.
Date of Approval: December 27, 1988

NADA 140-441 supplemental approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Effect of Supplement: This supplemental application amends the NADA to provide for the use of Baytril® Tablets in cats.
Date of Approval: May 31, 1990

NADA 140-441 supplemental approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Effect of Supplement: This supplemental application amends the NADA to remove the contradiction against use in breeding female dogs.
Date of Approval: June 6, 1990

NADA 140-441 supplemental approval
Sponsor: Bayer Corporation
Generic Name: enrofloxacin tablets and enrofloxacin injectable solution
Trade Name: Baytril® Antibacterial Tablets and Baytril® Antibacterial Injectable Solution
Effect of Supplement: Revises dosage frequency, indications, and limitations.
Date of Approval: June 18, 1997

NADA 140-441 supplemental approval
Sponsor: Bayer Corp., Agriculture Division, Animal Health Division
Generic Name: enrofloxacin
Trade Name: Baytril® Taste Tabs™ Antibacterial Tablets
Effect of Supplement: For the management of diseases in dogs and cats associated with bacteria susceptible to enrofloxacin.
Date of Approval: August 3, 1999

NADA 140-441 supplemental approval
Sponsor: Bayer HealthCare LLC, Animal Health Division
Generic Name: enrofloxacin
Trade Name: Baytril® Taste Tabs™ Antibacterial Tablets and Baytril® Antibacterial Tablets
Effect of Supplement: This supplement lowers the dose in cats to 5 mg/kg (2.27 mg/lb) of body weight either as a single dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals, and provides for the addition of post-approval adverse drug experience information and fluoroquinolone class safety statements in labeling regarding retinal toxicity in cats.
Date of Approval: February 23, 2001

NADA 140-442 original approval
Sponsor: Med-Tech, Inc.
Generic Name: xylaxine HCl
Trade Name: Xylazine HCl Injection
Indications for Use: Xylazine HCl Injection should be used in horses when it is desirable to produce a state of sedation. It has been successfully used when conducting various diagnostic, orthopedic and dental procedures and for minor surgical procedures of short duration. It may also be used as a preanesthetic to local or general anesthesia.
Date of Approval: February 18, 1988

NADA 140-443 original approval
Sponsor: Arkansas Micro Specialties, Inc.
Generic Name: hygromycin B
Trade Name: Hygromix 0.6 and 1.6 Premixes
Indications for Use: SWINE: Control of infestations of large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis). CHICKENS: Control of infestations of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). Discontinue swine feeds containing hygromycin B 15 days before slaughter. Discontinue chicken feeds containing hygromycin B 3 days before slaughter.
Date of Approval: May 30, 1986

NADA 140-445 original approval
Sponsor: Elanco Products Company
Generic Name: narasin + roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
Trade Name: Monteban® + Roxarsone
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by bacteria that are more susceptible to roxarsone combined with narasin than to narasin alone.
Date of Approval: June 28, 1988

NADA 140-448 original approval
Sponsor: Roussel-Uclaf
Generic Name: oxytetracycline + salinomycin sodium
Trade Name: Terramycin + Bio-Cox
Indications for Use: As an aid in the reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima .
Date of Approval: April 13, 1990

NADA 140-474 original approval
Sponsor: Sterivet Laboratories Limited
Generic Name: hyaluronate sodium
Trade Name: Synacid™
Indications for Use: For the treatment of equine carpal and fetlock joint dysfunction caused by traumatic and/or degenerative joint disease of mile to moderate severity.
Date of Approval: June 1, 1988

NADA 140-530 original approval
Sponsor: Agri-Basics
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: June 3, 1986