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U.S. Department of Health and Human Services

Animal & Veterinary

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140-921 to 141-060

NADA 140-921 original approval
Sponsor: VET-A-MIX, Inc.
Generic Name: Prednisolone, USP oral tablet 5.0 mg
Trade Name: PrednisTab™
Indications for Use: PrednisTab™ is intended for use in dogs. The indications for PrednisTab™ are the same as those for other anti-inflammatory steroids and comprise the various collagen, dermal, allergic, ocular, otic, and musculoskeletal conditions known to be responsive to the anti-inflammatory corticosteroids.
Date of Approval: November 8, 1991

NADA 140-921 supplemental approval
Sponsor: Lloyd, Incorporated
Generic Name: prednisolone, USP
Trade Name: PrednisTab®
Effect of Supplement: Provides for a new 20 mg tablet size.
Date of Approval: November 20, 1997

NADA 140-926 original approval
Sponsor: Elanco Animal Health, Division of Eli Lilly & Co.
Generic Name: Narasin/nicarbazin, bacitracin, methylene, disalicylate
Trade Name: Maxiban®/BMD®
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 and improved feed efficiency in broiler chickens.
Date of Approval: January 4, 1999

NADA 140-927 original approval
Sponsor: Intervet America, Inc.
Generic Name: chorionic gonadotropin
Trade Name: CHORULON®
Indications for Use: CHORULON is indicated for the intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.
Date of Approval: November 22, 1991

NADA 140-927 supplemental approval
Sponsor: Intervet Inc.
Generic Name: chorionic gonadotropin
Trade Name: Chorulon®
Effect of Supplement: Provides for the use of chorionic gonadotropin (Chorulon® ) as an aid in improving spawning function in male and female brood finfish.
Date of Approval: August 6, 1999

NADA 140-929 original approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin Phosphate
Trade Name: MICOTIL® 300
Indications for Use: For the treatment of respiratory disease (BRD) associated with Pasteurella haemolytica in cattle.
Date of Approval: March 3, 1992

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin injection USP
Trade Name: Micotil® 300
Effect of Supplement: Provides for the use of tilmicosin phosphate (Micotil® 300) in cattle for a new therapeutic claim.
Date of Approval: December 30, 1996

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Micotil® 300 Injection
Effect of Supplement: Deletes the following statements from the label: "A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal."
Date of Approval: December 23, 1997

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Micotil® 300 Injection
Effect of Supplement: This supplemental application provides for the addition of a new species, sheep.
Date of Approval: September 4, 2002

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin phosphate
Trade Name: MICOTIL 300
Effect of Supplement: To provide user safety information on the product labeling related to the mechanism of toxicity and medical intervention.
Date of Approval: December 2, 2005

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin
Trade Name: MICOTIL 300
Effect of Supplement: To add Pasteurella multocida and Histophilus somni to the indication “For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni” in beef and non-lactating dairy cattle.
To establish a dose range of 10 to 20 mg tilmicosin/kg body weight in beef and non-lactating dairy cattle for the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica.
Date of Approval: December 30, 2009

NADA 140-934 original approval
Sponsor: SmithKline Beecham Animal Health
Generic Name: Albendazole
Trade Name: VALBAZEN®
Indications for Use: For the removal and control of the following endoparasites infecting sheep: A.Liver flukes;
B.Tapeworms; C.Lungworms; D.Stomach worms; E.Intestinal worms
Date of Approval: November 10, 1994

NADA 140-937 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin Sodium, Bacitracin Methylene Disalicylate
Trade Name: COBAN®, and BMD®, No Trade Name Proposed for Combination
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: November 18, 1994

NADA 140-937 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, bacitracin methylene disalicylate
Trade Name: COBAN®, BMD®
Effect of Supplement: This supplemental application provides for a new combination including bacitracin methylene disalicylate, as an aid in the control of transmissible enteritis complicated by susceptible organisms at a new use level, when used in Type C medicated feeds in combination with monensin for the prevention of coccidiosis.
Date of Approval: August 13, 1998

NADA 140-940 original approval
Sponsor: Pfizer Inc.
Generic Name: semduramicin sodium
Trade Name: AVIAX®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix and E. mivati/mitis.
Date of Approval: March 10, 1994

NADA 140-942 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin and nicarbazin, bambermycins
Trade Name: Maxiban® plus Flavomycin®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: March 8, 2001

NADA 140-947 original approval
Sponsor: Elanco Animal Health
Generic Name: Narasin/nicarbazin
Trade Name: Mexiban®, Lincomix®
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 increase in rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: September 3, 1998

NADA 140-951 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: Diclazuril
Trade Name: Clinacox™
Indications for Use: For the prevention of coccidiosis by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (E. mivati), and E. maxima In broiler chicken.
Date of Approval: April 21, 1999

NADA 140-951 original approval
Sponsor: Schering-Plough Aminal Health
Generic Name: Diclazuril
Trade Name: Clinacox™
Indications for Use: Broiler Chickens:
For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.
Date of Approval: September 21, 2001

NADA 140-954 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole, lincomycin
Trade Name: Lincomix®, Type “A” Medicated Article (Premix)
Indications for Use: Fenbendazole is indicated for the removal of: LUNGWORMS; GASTROINTESTINAL WORMS; KIDNEYWORMS ..1. increased rate of weight gain in growing-finishing swine 2. for control of swine dysentery; for use in swine on premises with a history of swine dysentery, but where symptoms have not yet occurred 3. for treatment swine dysentery 4. for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.
Date of Approval: July 9, 1992

NADA 140-955 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin, Bambermycin
Trade Name: COBAN®, FLAVOMYCIN®
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: June 28, 2000

NADA 140-958 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: phenylbutazone paste
Trade Name: Equiphen Paste
Indications for Use: For relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: May 14, 1993

NADA 140-971 original approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin and pyrantel (as pamoate salt)
Trade Name: HEARTGARD-30® Plus
Indications for Use: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel pamoate (for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum and Uncinaria stenocephala) in dogs.
Date of Approval: January 15, 1993

NADA 140-971 supplemental approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin; pyrantel (as pamoate salt)
Trade Name: Heartgard™ Plus
Effect of Supplement: This supplement expands the indications to include the treatment and control of adult hookworms (Ancylostoma braziliense).
Date of Approval: October 3, 1996

NADA 140-973 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: clenbuterol hydrochloride
Trade Name: VENTIPULMIN® SYRUP
Indications for Use: Ventipulmin® Syrup (clenbuterol hydrochloride) is indicated for use in the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).
Date of Approval: May 11, 1998

NADA 140-974 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: IVOMEC® Premix for Swine
Indications for Use: For the treatment and control of GASTROINTESTINAL ROUNDWORMS; KIDNEYWORMS; LUNGWORMS; lice and mange mites when incorporated into complete swine feeds.
Date of Approval: September 23, 1993

NADA 140-974 supplemental approval
Sponsor: Merck Research Laboratories
Generic Name: Ivermectin
Trade Name: IVOMEC® Premix for Swine
Effect of Supplement: To add the label claim for treatment of breeding swine.
Date of Approval: July 27, 1995

NADA 140-974 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: IVOMEC® Premix for Swine
Effect of Supplement: New claim for the treatment and control of threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets via the colostrum or milk, when fed during gestation) and use of Type C medicated feed as a top dress for adult swine.
Date of Approval: August 10, 1998

NADA 140-976 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: neomycin sulfate
Trade Name: Neomix® 325 Medicated Premix / Neomix® AG 325 Medicated Premix
Effect of Supplement: Provides for the finalization of NAS/NRC/DESI review of Neomycin Sulfate Type A Medicated Articles.
Date of Approval: November 3, 1999

NADA 140-988 original approval
Sponsor: Merck Research Laboratories
Generic Name: Ivermectin
Trade Name: IVOMEC® SR Bolus for Cattle
Indications for Use: The Ivomec® SR Bolus is indicated for (1) the treatment of established infections and, throughout its approximately 135-day invermectin delivery period, prevents the establishment of infection by newly ingested larvae of certain nematode species, (2) treatment of established infections of certain mange mites, (3) treatment of established infections of certain sucking lice, (4) control of existing Hypoderma larvae or grubs and newly acquired larvae during the 135-day period, and (5) control of the tick Amblyomma americanum by interfering with engorgement with blood and completion of the reproductive portion of the young adult female life cycle.
Date of Approval: November 18, 1996

NADA 140-988 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec® SR Bolus for Cattle
Effect of Supplement: Provides for reducing the predicted duration of effectiveness from "approximately 135 days" to "approximately 130 days".
Date of Approval: June 21, 2000

NADA 140-989 original approval
Sponsor: Western Chemical, Inc.
Generic Name: formalin
Trade Name: PARASITE-S®
Indications for Use: A. Formalin is indicated for the control of external parasites on cultured food fishes: salmon, trout, catfish, largemouth bass, and bluegill sunfish. Organisms controlled include the protozoa: Ichthyophthirius spp. ("Ich"), Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp. and monogenetic trematodes: Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.; B. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.
Date of Approval: July 31, 1992

NADA 140-989 supplemental approval
Sponsor: Western Chemical Inc.
Generic Name: formalin
Trade Name: PARASITE-S®
Effect of Supplement: To add a new species, new claims, new dosages, and new treatment regimens.
Date of Approval: September 30, 1993

NADA 140-989 supplemental approval
Sponsor: Western Chemical, Inc.
Generic Name: Formalin
Trade Name: Parasite-S
Effect of Supplement: The approval will allow for the use of formalin to be expanded, as aparasiticide, to all finfish, and, as a fungicide, to the eggs of all finfish.
Date of Approval: June 18, 1998

NADA 140-992 original approval
Sponsor: Roussel Uclaf
Generic Name: trenbolone acetate and estradiol
Trade Name: Revalor®-H
Indications for Use: For increased rate of weight gain and improved feed efficiency in heifers fed in confinement for slaughter.
Date of Approval: December 13, 1994

NADA 140-992 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-200
Effect of Supplement: This supplemental application provides for the use of a higher dose ear implant for steers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency.
Date of Approval: November 29, 1999

NADA 140-992 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-IH
Effect of Supplement: Provides for the administration of a dose of 80 mg trenbolone acetate and 8 mg estradiol in heifers fed in confinement for slaughter for increased rate of weight gain.
Date of Approval: June 19, 2000

NADA 140-992 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-200
Effect of Supplement: Provides for the administration of REVALOR®-200
to heifers fed in confinement for slaughter.
Date of Approval: December 6, 2001

NADA 140-992 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: REVALOR-H, REVALOR-IH, Revalor®-200
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 140-994 original approval
Sponsor: Lloyd, Inc.
Generic Name: Tolazoline Hydrochloride, USP, Sterile Solution
Trade Name: Tolazine™Injection
Indications for Use: Tolazine should be used in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.
Date of Approval: April 19, 1996

NADA 140-998 original approval
Sponsor: SmithKline Beecham Animal Health
Generic Name: virginiamycin
Trade Name: V-Max™
Indications for Use: For increased rate of weight gain, for improved feed efficiency, and for reduction in the incidence of liver abscesses in cattle fed in confinement for slaughter.
Date of Approval: June 24, 1994

NADA 140-999 original approval
Sponsor: Orion Corporation
Generic Name: medetomidine hydrochloride
Trade Name: Domitor®
Indications for Use: Domitor is indicated for use as a sedative and analgesic in dogs over 12 weeks of age, to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The IV route of administration is more efficacious for dental care.
Date of Approval: March 19, 1996

NADA 141-002 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: OXY 500 Calf Bolus / OXY 1000 Calf Bolus
Indications for Use: For the control and treatment of the following diseases of beef and dairy calves caused by organisms sensitive to oxytetracycline; bacterial entertis caused by Salmonella typhimurium and Escherichia coli (colibacillosis); bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.
Date of Approval: October 26, 1998

NADA 141-007 original approval
Sponsor: Miles, Inc.
Generic Name: praziquantel + pyrantel Pamoate + febantel
Trade Name: Drontal™ Plus Broad Spectrum Anthelmintic Tablets
Indications for Use: Drontal™ Plus Broad Spectrum Anthelmintic Tablets are indicated for the removal of tapeworms, hookworms, ascarids, whipworms in dogs.
Date of Approval: May 19, 1994

NADA 141-007 supplemental approval
Sponsor: Bayer Corporation
Generic Name: Praziquantel + Pyrantel Pamoate + Febantel
Trade Name: Drontal™ Plus Broad Spectrum Anthelmintic Tablets
Effect of Supplement: This supplemental application amends NADA 141-007, Drontal™ Plus Broad Spectrum Anthelmintic Tablets, by adding the tape-worm Echinococcus multilocularis claim to the label.
Date of Approval: March 28, 1996

NADA 141-007 supplemental approval
Sponsor: Bayer Corporation Agricultural Division
Generic Name: Praziquantel + Pyrantel Pamoate + Febantel
Trade Name: Drontal™ Plus Broad Spectrum Anthelmintic Tablets
Effect of Supplement: Effect of Supplement: This supplement amends the NADA to provide for a larger tablet containing 136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate and 680.4 mg febantel and the associated label changes.
Date of Approval: February 10, 2003

NADA 141-007 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: praziquantel/pyrantel pamoate/febantel
Trade Name: DRONTAL Plus TASTE TABS
Effect of Supplement: This supplement amends the approved NADA by adding a flavored tablet formulation with the same indications.
Date of Approval: January 12, 2006

NADA 141-008 original approval
Sponsor: Miles Inc.
Generic Name: praziquantel + pyrantel pamoate
Trade Name: Drontal™ Tablets
Indications for Use: Drontal Tablets will remove Tapeworms (Dipylidium caninum, Taenia taeniaeformis ), Hookworms (Ancylostoma tubaeforme ) and Large Roundworms (Toxocara cati ) in kittens and cats.
Date of Approval: September 29, 1993

NADA 141-017 original approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: Saraflox® WSP
Indications for Use: Saraflox® WSPis indicated in growing broiler chickens and growing turkeys for the control of mortality associated with E. coli organisms sensitive to sarafloxacin hydrochloride.
Date of Approval: August 18, 1995

NADA 141-018 original approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: SaraFlox® Injection
Indications for Use: SaraFlox® Injection is indicated for control of early mortality associated with Escherichia coli (colibacillosis) susceptible to sarafloxacin in day-old broiler chickens.
Date of Approval: March 28, 1996

NADA 141-018 supplemental approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: SaraFlox® Injection
Effect of Supplement: This supplement provides for the addition of a new dose for in ovo administration to 18-day embryonated broiler eggs, to be added to the previously approved product, SaraFlox® Injection.
Date of Approval: January 21, 1997

NADA 141-025 original approval
Sponsor: Syntex Animal Health
Generic Name: laidlomycin propionate potassium
Trade Name: Cattlyst®
Indications for Use: For increased rate of weight gain and improved feed efficiency of cattle fed in confinement for slaughter.
Date of Approval: March 4, 1994

NADA 141-025 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: laidlomycin propionate potassium
Trade Name: Cattlyst®
Effect of Supplement: Codification of Acceptable Daily Intake (ADI) and establishment of a Tolerance for residues.
Date of Approval: May 12, 2003

NADA 141-026 original approval
Sponsor: Ciba Animal Health
Generic Name: lufenuron suspension
Trade Name: Program® Suspension
Indications for Use: Program® Suspension is indicated for use in cats, six weeks of age and older, for the control of flea populations.
Date of Approval: March 28, 1995

NADA 141-026 supplemental approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron suspension
Trade Name: Program® Suspension
Effect of Supplement: Change from Rx to Over the Counter and addition of an Adverse Reactions section to the product label.
Date of Approval: December 31, 1996

NADA 141-029 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: desoxycorticosterone pivalate
Trade Name: Percorten™-V
Indications for Use: For use as a replacement therapy for the mineralocoricoid dificit in dogs with primary adrenocortical insufficiency.
Date of Approval: January 12, 1998

NADA 141-033 original approval
Sponsor: Pfizer
Generic Name: atipamezole hydrochloride
Trade Name: Antisedan®
Indications for Use: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs.
Date of Approval: August 6, 1996

NADA 141-033 supplemental approval
Sponsor: Orion Corporation
Generic Name: atipamezole hydrochloride
Trade Name: ANTISEDAN
Effect of Supplement: An additional indication for the reversal of the sedative and analgesic effects of DEXDOMITOR (dexmedetomidine hydrochloride).
Date of Approval: December 1, 2006

NADA 141-034 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Flavomycin®
Effect of Supplement: A previous approval (58 FR 54286; October 21, 1993) provided for the use of bambermycins in complete feeds for increased rate of weight gain and improved feed efficiency of cattle fed in confinement for slaughter. This approval provides for the same dosage range of 10 to 20 mg bambermycins/head/day for increased rate of weight gain in pasture cattle (slaughter, stocker and feeder cattle) when fed daily in a least one pound of supplemental feed (Type C Medicated feed).
Date of Approval: March 14, 1994

NADA 141-034 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Gainpro™
Effect of Supplement: 21 CFR 558.95 currently provides for the use of bambermycins in cattle fed in confinement for slaughter for improved feed efficiency and increased rate of weight gain, and for increased rate of weight gain in pasture cattle. This supplement provides for use of a generic formulation of loose mineral free-choice Type C medicated feed for free-choice supplementation to pasture cattle.
Date of Approval: July 9, 1996

NADA 141-034 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Bambermycins
Trade Name: GAINPRO ™
Effect of Supplement: 21 CFR 558.95 currently provides for the use of bambermycins in cattle fed in confinement for slaughter for improved feed efficiency and increased rate of weight gain, and for increased rate of weight gain in pasture cattle. This supplement provides for use of loose mineral free-choice Type C medicated feed (Trade Name: Vigortone GP Grazer) for free-choice supplementation to pasture cattle.
Date of Approval: March 10, 1998

NADA 141-034 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Bambermycins
Trade Name: GAINPRO ™
Effect of Supplement: provides for the removal of the caution statement "Not for Use in Animals Intended for Breeding" in feedlot and pasture cattle, and the addition of dairy and beef replacement heifers to the indications for use in pasture cattle.
Date of Approval: June 29, 1998

NADA 141-034 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Bambermycins
Trade Name: GAINPRO ™
Effect of Supplement: To provide for free-choice and hand-fed consumption of bambermycins at a rate of not less than 10 mg nor more than 40 mg per head per day to increase rate of weight gain in pasture cattle.
Date of Approval: February 10, 2003

NADA 141-035 original approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron tablets
Trade Name: PROGRAM® Tablets
Indications for Use: PROGRAM Tablets are indicated for use in dogs, six weeks of age and older, for the prevention and control of flea populations.
Date of Approval: November 23, 1994

NADA 141-035 supplemental approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron tablets
Trade Name: Program® Tablets
Effect of Supplement: Change from Rx to Over the Counter and addition of an Adverse Reactions section to the product label.
Date of Approval: December 31, 1996

NADA 141-035 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: lufenuron
Trade Name: Program® Cat Tabs
Effect of Supplement: Approval of the supplemental NADA will change NADA 141-035 by adding the indication for the use of lufenuron tablets in cats and kittens, six weeks of age or older, at a minimum dose of 30 mg/kg for the control of flea populations. The cat [sic] will have labeling separate from the original dog approval.
Date of Approval: January 23, 1997

NADA 141-035 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron Tablets
Trade Name: Program® Flavor Tabs™
Effect of Supplement: This supplemental provides for adding a flavored tablet formulation with the same indications as the non-flavored tablets.
Date of Approval: August 1, 1998

NADA 141-035 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron
Trade Name: Program® Flavor Tabs™
Effect of Supplement: This supplemental application provides for labeling changes reflecting the concurrent use with Capstar® (nitenpyram) Tablets (NADA 141-175) and reflecting a decrease in the minimum age from 6 weeks to 4 weeks.
Date of Approval: June 11, 2003

NADA 141-036 original approval
Sponsor: The Upjohn Company
Generic Name: pirlimycin hydrochloride aqueous gel
Trade Name: Pirsue™ Aqueous Gel
Indications for Use: Pirlimycin is indicated for the treatment of clinical and subclinical mastitis in lactating dairy cattle. Pirlimycin has been proven effective only against Staphylococcus species such as Staphylococcus aureus and Streptococcus species such as Streptococcus agalactiae, Stretococcus dysgalactiae, and Streptococcus uberis. Cows with systemic clinical signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.
Date of Approval: September 10, 1993

NADA 141-036 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: pirlimycin hydrochloride
Trade Name: PIRSUE® Sterile Solution
Effect of Supplement: Provides for a new sterile formulation with the same therapeutic claims. Also, provides for an Acceptable Daily Intake, a tolerance in cattle muscle, and a 9-day pre-slaughter withdrawal period.
Date of Approval: September 7, 2000

NADA 141-036 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Pirlimycin hydrochloride
Trade Name: PIRSUE Sterile Solution
Effect of Supplement: This supplement provides for an extended duration of therapy dosage regimen.
Date of Approval: December 12, 2007

NADA 141-038 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: polysulfated glycosaminoglycan (PSGAG)
Trade Name: Adequan® Canine
Indications for Use: Intramuscular injection for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints.
Date of Approval: July 15, 1997

NADA 141-040 original approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: Celerin™
Indications for Use: For increased rate of weight gain and improved feed efficiency in steers and in heifers which will not be used for reproduction.
Date of Approval: June 25, 2003

NADA 141-040 supplemental approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: CELERIN
Effect of Supplement: This supplement provides for the addition of the suckling beef calf indication “For increased rate of weight gain,” originally approved under NADA 141-041 as CELERIN C to CELERIN. In addition it updates the dosage administration for suckling beef calves to 0.5 mL (10 mg). This supplement also provides for a change in the indication and dosage to allow use for increased rate of weight gain in steers fed in confinement for slaughter, previously at 10 mg (0.5 mL) to 20 mg (1.0 mL). In addition, this supplement also provides for a new 10 mL vial size.
Date of Approval: January 19, 2006

NADA 141-041 original approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: Celerin™ C
Indications for Use: For increased rate of weight gain in calves at least 30 days old which will not be used for reproduction and not used for veal.
Date of Approval: June 25, 2003

NADA 141-043 original approval
Sponsor: Syntex Animal Health, Division of Syntex Agribusiness, Inc.
Generic Name: trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Plus
Indications for Use: For improved feed efficiency in steers fed in confinement for slaughter.
Date of Approval: February 22, 1996

NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of American Home Products Corp.
Generic Name: Trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Plus
Effect of Supplement: This supplement provides for the implantation of Synovex® Plus in heifers fed in confinement for slaughter for increased rate of weight gain.
Date of Approval: Septemeber 30, 1998

NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of American Home Products Corp.
Generic Name: Trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Plus
Effect of Supplement: provides for implanatation in steers fed in confinement for slaughter for increased rate of weight gain and the establishment of an ADI for trenbolone.
Date of Approval: March 16, 1999

NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Choice
Effect of Supplement: provides for use at an additional dosing level.
Date of Approval: October 3, 2002

NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Trenbolone Acetate and Estradiol Benzoate
Trade Name: SYNOVEX Choice and SYNOVEX PLUS
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 141-043 supplemental approval
Sponsor: Zoetis Inc.
Generic Name: Trenbolone Acetate and Estradiol Benzoate
Trade Name: SYNOVEX Choice®
Effect of Supplement: This supplement provides for the addition of a new indication for increased rate of weight gain and improved feed efficiency in heifers fed in confinement for slaughter.
Date of Approval: August 3, 2014

NADA 141-044 original approval
Sponsor: Peptech Animal Health Pty, Limited
Generic Name: Deslorelin Acetate
Trade Name: Ovuplant ™
Indications for Use: For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 mm in diameter.
Date of Approval: June 18, 1998

NADA 141-047 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: butorphanol
Trade Name: Torbugesic-SA (butorphanol) Veterinary Injection
Indications for Use: Torbugesic-SA (butorphanol tartrate, USP) is indicated for the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Date of Approval: July 5, 1994

NADA 141-051 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin heartworm prevention tablets
Trade Name: ProHeart™ for Dogs
Indications for Use: To prevent infections by the canine heartworm, Dilofilaria immitis, and the subsequent development of canine heartworm disease.
Date of Approval: May 27, 1997

NADA 141-052 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: 0.2% cyclosporine opthalmic ointment
Trade Name: Optimmune® Opthalmic Ointment
Indications for Use: For the treatment of chronic keratoconjunctivitis sicca (KCS) in dogs.
Date of Approval: August 2, 1995

NADA 141-052 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: 0.2% cyclosporine USP ophthalmic ointment
Trade Name: Optimmune® ophthalmic ointment
Effect of Supplement: To add the label claim for the management of chronic superficial keratitis (CSK) in dogs. In addition, the label claim for treatment of chronic keratoconjunctivis sicca (KCS) was changed to management of chronic KCS. The term management reflects the complexity of therapy for the two diseases.
Date of Approval: August 26, 1997

NADA 141-053 original approval
Sponsor: Pfizer Inc.
Generic Name: carprofen
Trade Name: Rimadyl®
Indications for Use: RIMADYL® is indicated for the relief of pain and inflammation in dogs. RIMADYL was shown to be clinically effective for the reflief of signs associated with osteoarthritis in dogs.
Date of Approval: October 25, 1996

NADA 141-053 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: carprofen
Trade Name: Rimadyl® Caplets
Effect of Supplement: This supplement provides for flexibility in administration of the total daily dose of Rimadyl® caplets. The drug may be administered orally at 2 milligrams per pound of body weight once daily or 1 milligram per pound of body weight twice daily.
Indications for Use: Rimadyl® is indicated for the relief of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: September 27, 2001

NADA 141-053 supplemental approval
Sponsor:
Pfizer Inc.
Generic Name: carprofen
Trade Name: Rimadyl® Caplets
Effect of Supplement: To add a claim for the control of postoperative pain associated with soft tissue and orthopedic surgery in dogs.
Date of Approval: April 25, 2002

NADA 141-054 original approval
Sponsor: Merck Research Laboratories
Generic Name: Ivermectin and lincomycin
Trade Name: IVOMEC® Premix for Swine, Type A Medicated Article and LINCOMIX® Premix, Type A Medicated Article
Indications for Use: Ivermectin: For the treatment and control of gastrointestinal roundworms, kidneyworms, lungworms, lice and mange mites in swine. Lincomycin: for increased rate of weight gain, for treatment and control of swine dysentery, and for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae in swine.
Date of Approval: March 28, 1996

NADA 141-059 original approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin methylene disalicylate, chlortetracycline
Trade Name: BMD®-25, BMD®-30, BMD®-40, BMD®--50, BMD®-60, or BMD®-75 and CTC®50, CTC®65, CTC®70, or Micro-CTC®100
Indications for Use: Bacitracin methylene disalicylate Type A Medicated Articles (NADA 46-592): For increased rate of weight gain and improved feed efficiency. Chlortetracycline Type A Medicated Articles (NADA 46-699): For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
Date of Approval: September 18, 1996

NADA 141-059 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin methylene disalicylate chlortetracycline
Trade Name: BMD®10 BMD®25, BMD®30, BMD®40, BMD®50, BMD®60, or BMD®75 and CTC®50, CTC®65, CTC®70 Type A Medicated Articles
Effect of Supplement: This supplemental approval provides for using currently approved, single ingredient, Type A medicated articles in making combination drug Type B medicated swine feeds containing bacitracin methylene disalicylate and chlortetracycline.
Date of Approval: June 24, 1998

NADA 141-059 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: chlortetracycline (CTC), bacitracin methylene disalicylate (BMD)
Trade Name: ChlorMax™ 50, ChlorMax™ 65, or ChlorMax™ 70 and BMD® -25, BMD® -30, BMD® -40, BMD® -50, BMD® -60 or BMD® -75 Type A Medicated Articles
Effect of Supplement: adds the claim for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline to approved combination label indications.
Date of Approval: July 7, 2000

NADA 141-060 original approval
Sponsor: Alpharma, Inc.
Generic Name: Decoquinate
Trade Name: Deccox® -M Medicated Powder for Whole Milk
Indications for Use: DECCOX®-M is indicated for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii in ruminating and non-ruminating calves, including veal calves.
Date of Approval: January 14, 1999