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U.S. Department of Health and Human Services

Animal & Veterinary

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141-061 to 141-160

NADA 141-061 original approval
Sponsor: Pfizer Inc.
Generic Name: Doramectin 1% injectable solution
Trade Name: Dectomex® Injectable Solution
Indications for Use: For the treatment and control of certain nematode and arthropod parasites in cattle.
Date of Approval: July 30, 1996

NADA 141-061 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin 1% injectable solution
Trade Name: Dectomax® Injectable Solution
Effect of Supplement: New claims for persistent ocntrol of gastrointestinal roundworms and lungworms in cattle.
Date of Approval: July 18, 1997

NADA 141-061 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: doramectin 1% injectable solution
Trade Name: Dectomax® Injectable Solution
Effect of Supplement: Adds swine to the previously approved NADA.
Date of Approval: September 18, 1997

NADA 141-061 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: doramectin
Trade Name: Dectomax® 1% Injectable Solution For Cattle and Swine
Effect of Supplement: Provides for the addition of persistent efficacy to protect cattle from reinfection with Cooperia oncophora for 14 days and Oesophagostomum radiatum for 28 days after treatment.
Date of Approval: October 25, 1998

NADA 141-061 original approval
Sponsor: Pfizer Inc.
Generic Name: doramectin
Trade Name: Dectomax® 1% Injectable Solution For Cattle and Swine
Effect of Supplement: New indication for persistent control of nematodes in cattle adding protection against Haemonchus placei for 14 days after treatment.
Date of Approval: February 1, 1999

NADA 141-062 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: lufenuron
Trade Name: Program® Cat Flavor Tabs™
Indications for Use: Program Cat Flavor Tabs are indicated for use in cats and kittens, six weeks of age and older, for the control of flea populations.
Date of Approval: March 3, 1997

NADA 141-063 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: florfenicol
Trade Name: NUFLOR® Injectable Solution
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, Pasteurella multocida,and Haemophilus somnus.
Date of Approval: May 31, 1996

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Label changes to standardize the veal calf residue warning and remove a graphic box from the Warnings section.
Date of Approval: April 2, 1998

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Provides for the use of a subcutaneous route of administration for Nuflor® Injectable Solution in cattle.
Date of Approval: June 4, 1998

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Provides for the use of florfenicol (Nuflor®Injectable Solution) as a single subcutaneous injection in cattle at high risk of developing bovine respiratory disease (BRD).
Date of Approval: December 17, 1998

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Provides for the use of florfenicol (Nuflor®Injectable Solution) for treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Date of Approval: January 14, 1999

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: NUFLOR Injectable Solution
Effect of Supplement: The effect of this supplement is to add information describing florfenicol’s in vitro bactericidal activity against some strains of Mannheimia haemolytica and Histophilus somni to the microbiology section of the product labeling.
Date of Approval: November 14, 2006

NADA 141-064 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly and Company
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90
Indications for Use: Pulmotil® 90 is indicated for the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.
Date of Approval: December 17, 1996

NADA 141-064 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90 Type A Medicated Article
Effect of Supplement: 1. The addition of the following caution statement to labeling.
“Caution: Do not allow horses or other equine access to feeds containing tilmicosin.”
2. The codification under 21 CFR 556.735, of an acceptable daily intake (ADI) in man and a muscle tolerance for parent tilmicosin in swine muscle.
Date of Approval: February 2, 1999

NADA 141-064 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90
Effect of Supplement: Changes to the label are 1) removal of the MIC chart; 2) additions to the Pharmacology section of the label; 3) additional CAUTION that discourages continuous use for more than 21 days and limits use of each VFD form to 90 days. Changes to the VFD are inclusion of the additional CAUTION like the label and 2) addition of a 90-day maximum for the expiration of the VFD.
Date of Approval: November 15, 2001

NADA 141-064 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin phosphate
Trade Name: PULMOTIL 90
Effect of Supplement: To allow for use in female breeding swine for the existing indication “For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.”
Date of Approval: November 24, 2004

NADA 141-064 supplemental approval
Sponsor: Elanco Animal Health, A division of Eli Lilly & Co.
Generic Name: Tilmicosin phosphate
Trade Name: Pulmotil® 90
Effect of Supplement: The supplemental NADA provides for the use of tilmicosin Type C medicated feeds by veterinary feed directive for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and nonlactating dairy cattle where active BRD has been diagnosed in at least 10 percent of the animals in the group.
Date of Approval: August 19, 2011

NADA 141-065 original approval
Sponsor: Pfizer Inc.
Generic Name: Semduramicin, Bacitracin methylene disalicylate
Trade Name: Aviax ™, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella, and for improved feed efficiency in broiler chickens.
Date of Approval: October 18, 1996

NADA 141-066 original approval
Sponsor: Pfizer Inc.
Generic Name: semduramicin, roxarsone
Trade Name: Aviax™, 3-Nitro®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria acervulina, E. brunetti, E. mivati/mitis, E. necatrix, including some field strains of E. tenella that are more susceptible to semduramicin combined with roxarsone than semduramicin alone.
Date of Approval: November 7, 1997

NADA 141-067 original approval
Sponsor: Biopure Corporation
Generic Name: Hemoglobin glutamer-200 (bovine)
Trade Name: Oxyglobin
Indications for Use: Oxyglobin is indicated for the treatment of anemia in dogs by increasing systemic oxygen content (plasma hemoglobin concentration) and improving the clinical signs associated with anemia for at least 24 hours, regardless of the cause of anemia (hemolysis, blood loss, or ineffective erythropoiesis).
Date of Approval: January 12, 1998

NADA 141-067 supplemental approval
Sponsor: Biopure Corporation
Generic Name: Hemoglobin glutamer-200 (bovine)
Trade Name: Oxyglobin® Solution
Effect of Supplement: This supplement changes the original approval from a fixed dosage of 30 mL/kg to a flexible dosage range of 10-30 mL/kg.
Date of Approval: January 11, 2000

NADA 141-068 original approval
Sponsor: Bayer Corporation, Agriculture Division, Animal Health
Generic Name: Enrofloxacin
Trade Name: Baytril 100 Injectable Solution
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus.
Date of Approval: July 24, 1998

NADA 141-068 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: Enrofloxacin
Trade Name: BAYTRIL 100
Effect of Supplement: To provide for the use of enrofloxacin in female dairy cattle less than 20 months of age.
Date of Approval: February 13, 2008

NADA 141-068 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: Enrofloxacin
Trade Name: BAYTRIL 100
Effect of Supplement: This supplement provides a new indication, for the treatment and control of swine respiratory disease, in swine.
Date of Approval: March 14, 2008

NADA 141-068 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: Enrofloxacin
Trade Name: BAYTRIL 100
Effect of Supplement: This supplement provides for the treatment of BRD associated with M. bovis in beef and non-lactating dairy cattle, when administered as a dose of 7.5 to 12.5 mg/kg BW (3.4 to 5.7 mL/100 lb BW) once by subcutaneous injection.
Date of Approval: March 10, 2011

NADA 141-068 supplemental approval
Sponsor: Bayer Healthcare LLC, Animal Health Division
Generic Name: Enrofloxacin
Trade Name: Baytril® 100
Indications for Use: This supplement provides for a new indication for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis..
Date of Approval: July 24, 2012

NADA 141-068 supplemental approval
Sponsor: Bayer Healthcare LLC, Animal Health Division
Generic Name: Enrofloxacin
Trade Name: Baytril® 100
Effect of Supplement: This supplement provides for the addition of two pathogens, Bordetella bronchiseptica and Mycoplasma hyopneumoniae to the SRD treatment and control indications.
Date of Approval: November 21, 2012

NADA 141-069 original approval
Sponsor: Alpharma, Inc.
Generic Name: colistimethate sodium
Trade Name: FIRST GUARD STERILE POWDER
Indications for Use: FIRST GUARD STERILE POWDER (colistimethate sodium) is indicated for use in 1- to 3- day-old chickens for the control of early mortality associated with Escherichia coli susceptible to colistin.
Date of Approval: January 13, 1998

NADA 141-070 original approval
Sponsor: Mallinkrodt Veterinary, Inc.
Generic Name: propofol
Trade Name: Rapinovet®
Indications for Use: Rapinovet®is an anesthetic injection for use in dogs as follows: a) as a single injection to provide general anesthesia for procedures lasting up to five minutes; b) for induction and maintenance of general anesthesia using incremental doses to effect; and c) for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
Date of Approval: November 7, 1996

NADA 141-070 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: propofol
Trade Name: Rapinovet®
Effect of Supplement: 1. The supplement supports the addition of a new species, cats, to the original approved dog application for the same anesthetic indications.
2. The supplement also contains changes to the original canine portions of the label and FOI Summary as follows:
a. Information concerning the use of medetomidine prior to propofol anesthesia in dogs will appear on the label as well as in the FOI Summary. Medetomidine is approved for use in dogs for sedation and analgesia.
b. The recommended preanesthetic medetomidine dose will be lowered from 10-40 ug/kg IM/IV to 5-10 ug/kg IM based on data already contained in the original new animal drug application (NADA) approval for propofol in dogs.
Date of Approval: January 14, 1999

NADA 141-071 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: imidocarb dipropionate
Trade Name: Imizol®
Indications for Use: For the treatment of babesiosis in dogs with clinical signs and/or demonstrated Babesia organisms in the blood.
Date of Approval: November 7, 1997

NADA 141-074 original approval
Sponsor: Wildlife Laboratories, Incorporated
Generic Name: naltrexone hydrochloride
Trade Name: Trexonil™
Indications for Use: For use as an antagonist to carfentanil citrate immobilization in free-ranging or confined elk and moose (Cervidae).
Date of Approval: December 23, 1996

NADA 141-075 original approval
Sponsor: Orphan Medical, Inc.
Generic Name: fomepizole
Trade Name: Antizol-Vet™ (fomepizole) for injection
Indications for Use: Antizol-Vet™ is indicated as an antidote for ethylene glycol (antifreeze) poisoning in dogs who have ingested or are suspected of having ingested ethylene glycol.
Date of Approval: November 25, 1996

NADA 141-077 original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: spectinomycin sulfate tetrahydrate
Trade Name: ADSPEC™ Sterile Solution
Indications for Use: ADSPEC™ Sterile Solution is indicated for the treatment of bovine respiratory disease (pneumonia) associated with Pasteurella haemolytica, Pasteurella multocida and Haemophilus somnus.
Date of Approval: January 28, 1998

NADA 141-078 original approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin
Trade Name: Heartgard® for Cats
Indications for Use: Heartgard® for Cats is indicated for the prevention of feline heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection, and for the removal and control of adult and immature (L4) hookworms (Ancylostoma tubaeforme and A. braziliense).
Date of Approval: December 23, 1996

NADA 141-079 original approval
Sponsor: Merck Research Laboratories
Generic Name: eprinomectin
Trade Name: Ivomec® Eprinex™ Pour-On
Indications for Use: For treatment and control of certain gastrointestinal nematodes, lungworms, cattle grubs, lice, mange mites, and flies.
Date of Approval: April 16, 1997

NADA 141-079 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Eprinomectin
Trade Name: Ivomec® Eprinex™ Pour-On for Beef and Dairy Cattle
Effect of Supplement: This supplemental application adds indications for the treatment and control of adult Strongyloides papillosus and adult Trichostrongylus longispicularis and removes the age restriction for use in cattle under 8 weeks of age
Date of Approval: August 9, 1998

NADA 141-080 original approval
Sponsor: Deprenyl Animal Health, Inc.
Generic Name: selegiline hydrochloride, the levorotatory form of deprenyl HCl
Trade Name: Anipryl®
Indications for Use: For the control of clinical signs associated with uncomplicated canine pituitary dependent hyperadrenocorticism (PDH).
Date of Approval: May 30, 1997

NADA 141-080 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: selegiline hydrochloride, the levorotatory form of deprenyl HCl
Trade Name: Anipryl®
Effect of Supplement: Provides for the addition of a new claim for the clinical signs associated with canine Cognitive Dysfunction Syndrome at a new dose of 0.5-1.0mg/kg.
Date of Approval: December 10, 1998

NADA 141-081 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: orbifloxacin
Trade Name: Orbax™
Indications for Use: For the management of diseases in dogs associated with bacteria susceptible to orbifloxacin; clinical efficacy was established in skin and soft tissue infections (wounds and abscesses) and urinary tract infections (cystitis) associated with bacteria susceptible to orbifloxacin.
Date of Approval: April 22, 1997

NADA 141-081 supplemental approval
Sponsor: Schering-Plough Animal Health
Generic Name: orbifloxacin tablets
Trade Name: Orbax™ tablets
Effect of Supplement: The supplement to NADA 141-081, for dogs, provides for revisions to 21 CFR 520.1616 and the use of Orbax (orbifloxacin) tablets in cats as indicated below.
§520.1616 Orbifloxacin tablets.
(d) Conditions of use. (1) Dogs and cats.
Date of Approval: September 18, 1997

NADA 141-081 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Orbifloxacin
Trade Name: ORBAX Tablets
Indications for Use: ORBAX Tablets (orbifloxacin) are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin.
Date of Approval: March 3, 2006

NADA 141-082 original approval
Sponsor: Heska Corporation
Generic Name: doxycycline hyclate
Trade Name: Heska™ Periodontal Disease Therapeutic
Indications for Use: The Heska Periodontal Disease Therapeutic is indicated for the treatment and control of periodontal disease in dogs.
Date of Approval: November 19, 1997

NADA 141-083 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid, Bacitracin Zinc
Trade Name: Avatec® plus Baciferm®
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: April 18, 2001

NADA 141-084 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel™ Tablets
Indications for Use: For use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm disease caused by Dirofilaria immitis, for the prevention and control of flea populations, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis, Toxocaris leonine (roundworm) and Trichuris vulpis (whipworm) infections.
Date of Approval: April 10, 1997

NADA 141-084 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel™ Flavor Tablets®
Effect of Supplement: Approval of this supplemental NADA will change NADA 141-084 by adding a flavored tablet formulation with the same indications. The flavored tablets (in three tablet sizes) will replace the swallow tablets for dogs ³ 11 pounds. The swallow tablet will remain for dogs between 2-10 lbs.
Date of Approval: June 17, 1998

NADA 141-084 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel™ Flavor Tablets®
Effect of Supplement: Approval of this supplemental NADA will change the labeling for NADA 141-084.
1. There are some minor revisions to clarify the currently approved text in the package insert.
2. Use of the Client Information insert will be discontinued.
3. The package insert is revised to include reference to the concurrent use of CAPSTAR® (nitenpyram) Tablets (NADA 141-175) to kill adult fleas. The information supporting approval for this concurrent use is documented in NADA 141-204.
4. The unit dose cartons are revised to refer to concurrent use with CAPSTAR® Tablets.
5. Each unit dose carton will contain an additional “FLEA MANAGEMENT SYSTEM™” package insert that provides specific information for using CAPSTAR® Tablets with SENTINEL® Flavor Tabs®.
Date of Approval: June 11, 2003

NADA 141-085 original approval
Sponsor: Alpharma, Inc.
Generic Name: zoalene, bacitracin methylene disalicylate
Trade Name: ZOAMIX®,BMD®
Indications for Use: For the prevention and control of coccidiosis, for increased weight gain, and improved feed efficiency in growing turkeys.
Date of Approval: June 3, 1998

NADA 141-085 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: zoalene, bacitracin methylene disalicylate
Trade Name: Zoamix® , BMD®
Effect of Supplement: Provides for using approved single ingredient bacitracin methylene disalicylate and zoalene Type A medicated articles to make two-way combination drug Type C medicated feeds used for the management of necrotic enteritis and coccidiosis in replacement and broiler chickens.
Date of Approval: November 20, 2001

NADA 141-087 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: Quest™ moxidectin 2% Equine Oral Gel
Indications for Use: Quest moxidectin 2% Equine Oral Gel, when administered at the recommended dose level of 0.4 mg moxidectin/kg (2.2 lb) body weight, has been demonstrated to be effective in the treatment and control of certain stages of gastrointestinal parasites of horses and ponies.
Date of Approval: July 11, 1997

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of American Home Products
Generic Name: moxidectin
Trade Name: Quest™ 2% Equine Oral Gel
Effect of Supplement: a. New indication: For the treatment and control of Gasterophilus nasalis (3rd instars)
b. Labeling Change: The precautions section is revised to read “This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.” The photograph on the carton was changed to remove the picture of a young foal.
Date of Approval: October 4, 1999

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: moxidectin
Trade Name: Quest™ Gel
Effect of Supplement: Raise the minimum age limit for use of this product from 4 months up to 6 months of age.
Date of Approval: May 29, 2003

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: Quest® Gel
Indications for Use: For the treatment and control of the following stages of gastrointestinal parasites of horses and ponies six months of age and older which will not to be used for food: Large strongyles: Strongylus vulgaris (adult and L4/L5 arterial stages), Strongylus edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), Triodontophorus serratus (adults) Small strongyles (adults): Cyathostomum spp. including C. catinatum, C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus; Cylicostephanus spp. including C.calicatus, C. goldi, C. longibursatus, C. minutis; Coronocyclus spp., including C. coronatus, C. labiatus, C. labratus; Gyalocephalus capitatus; undifferentiated luminal larvae Encysted cyathostomes: late L3 and L4 mucosal cyathostome larvae Ascarids: Parascaris equorum (adults and L4 larval stages) Pinworms: Oxyuris equi (adults and L4 larval stages) Hairworms: Trichostrongylus axei (adults) Large-mouth stomach worms: Habronema muscae (adults) Horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars), G. nasalis (3rd instars) One dose also suppresses strongyles egg production for 84 days.
Date of Approval: March 17, 2004

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: QUEST Gel
Effect of Supplement: The supplement provides for the use of moxidectin gel for the treatment and control of adult Cylicocyclus radiatus and Petrovinema poculatus based on results from additional dose confirmation studies.
Date of Approval: November 23, 2005

NADA 141-088 original approval
Sponsor: Alpharma, Inc.
Generic Name: Nitarsone, Bacitracin methylene disalicylate
Trade Name: HISTOSTAT®, BMD®
Indications for Use: As an aid in the prevention of blackhead, for increased weight gain, and improved feed efficiency in growing turkeys.
Date of Approval: June 17, 1998

NADA 141-090 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril; Virginiamycin
Trade Name: Clinacox ™, Stafac®
Indications for Use: 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. For increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: January 13, 2000

NADA 141-095 original approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin 0.5% pour-on solution
Trade Name: Dectomax® Pour-On solution
Indications for Use: To control infections and to protect cattle from re-infection with Cooperia oncophora and Dictyocaulus viviparus for 21 days, and Ostertagia ostertagi, Cooperia puctata, and oesophagostomum radiatum for 28 days after treatment.
Date of Approval: September 16, 1997

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin
Trade Name: Dectomax® Pour-On solution for cattle
Effect of Supplement:  Adds to labeling a new indication for treatment and control of horn fly, Haematobia irritans
Date of Approval: October 25, 1998

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin
Trade Name: Dectomax® Pour-On
Effect of Supplement: Provides for addition of a therapeutic claim for Trichostrongylus axei L4 and a persistency claim of 35 days for Haemonchus placei.
Date of Approval: August 10, 1999

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Doramectin
Trade Name: DECTOMAX (doramectin) Pour-On
Effect of Supplement: For treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, mange mites and horn flies. To protect cattle from reinfection with Cooperia oncophora, D. viviparus, Ostertagia ostertagi, and O.radiatum for 28 days; and with C. punctata, and Haemonchus placei for 35 days after treatment.
Date of Approval: June 30, 2004

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc
Generic Name: Doramectin
Trade Name: DECTOMAX Pour-On
Effect of Supplement: This supplement allows the following additional persistent effect indications. DECTOMAX Pour-On solution has been proved to effectively control infestations and to protect cattle from reinfestation with Bovicola (Damalinia) bovis for 77 days and Linognathus vituli for 42 days after treatment.
Date of Approval: June 23, 2005

NADA 141-096 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: difloxacin hydrochloride
Trade Name: Dicural® Tablets
Indications for Use: To manage diseases in dogs associated with bacteria susceptible to difloxacin.
Date of Approval: November 20, 1997

NADA 141-097 original approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin, bacitracin methylene disalicylate
Trade Name: Ivomec® Premix for Swine + BMD®
Indications for Use: For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), 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), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis).
Date of Approval: February 3, 1999

NADA 141-098 Original Approval
Sponsor: Abbott Laboratories
Generic Name: Propofol
Trade Name: PROPOFLO™
Indications for Use: a. For induction of anesthesia.
b. For maintenance of general anesthesia for up to 20 minutes.
c. For induction of general anesthesia where maintenance is provided by inhalant anesthetics.
Date of Approval: March 13, 1998

NADA 141-098 Supplemental Approval
Sponsor: Abbott Laboratories
Generic Name: Propofol
Trade Name: PROPOFLO™
Effect of Supplement: The effect of the supplement is to add a preservative (benzyl alcohol) for a multidose presentation in a 20 mL vial..
Date of Approval: Feburary 4, 2011

NADA 141-099 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On for Cattle
Indications for Use: Effective in the treatment and control of external parasites. CYDECTIN® (moxidectin) 0.5% Pour-On for Cattle has been proven to effectively control infections and to protect cattle from reinfection with Ostertagia ostertagi for 28 days following treatment and Dictyocaulus viviparus for 42 days after treatment.
Date of Approval: January, 28, 1998

NADA 141-099 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On for Cattle
Effect of Supplement: This supplemental application provides for topical use of a 0.5% moxidectin solution on dairy cattle of breeding age for treatment and control of infections and infestations of certain internal and external parasites. In addition, the regulations are amended to establish a tolerance for moxidectin residues in milk.
Date of Approval: November 2, 1999

NADA 141-099 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On
Effect of Supplement: This supplemental application provides for treatment and control of infections of additional life stages and species of gastrointestinal roundworms for topical use of 0.5% moxidectin solution on cattle.
Date of Approval: June 18, 2001

NADA 141-100 original approval
Sponsor: Alpharma, Inc.
Generic Name: Decoquinate, bacitracin methylene disalicylate, roxarsone
Trade Name: DECCOX®,BMD®, 3-NITRO®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. nectrix, E. mivati, E. acervulina,
E. maxima, and E. brunetti,
as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed effeciency, and improved pigmentation in broiler chickens.
Date of Approval: June 2, 1998

NADA 141-101 original approval
Sponsor: BioScience
Generic Name: competitive exclusion culture
Trade Name: PREEMPT™
Indications for Use: PREEMPT™ is indicated for the early establishment of intestinal microflora in chickens to reduce Salmonella colonization.
Date of Approval: March 13, 1998

NADA 141-102 original approval
Sponsor: Alpharma Inc.
Generic Name: Decoquinate, Bacitracin methylene disalicylate
Trade Name: DECCOX®, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 24, 1998

NADA 141-103 original approval
Sponsor: Abbott Laboratories
Generic Name: Sevoflurane
Trade Name: SevoFlo™
Indications for Use: For induction and maintenance of general anesthesia.
Date of Approval: November 17, 1999

NADA 141-105 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron 10% Sterile Suspension Injectable
Trade Name: Program 6 Month Injectable for Cats
Indications for Use: Program 6 Month Injectable for Cats is indicated for use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Date of Approval: March 31, 1998

NADA 141-107 original approval
Sponsor: Alaco, Inc.
Generic Name: b -aminopropionitrile fumarate
Trade Name: BAPTEN® For Injection
Indications for Use: BAPTEN is indicated for the treatment of tendinitis of the superficial digital flexor tendon (SDFT) in the adult horse where there is sonographic evidence of fiber tearing.
Date of Approval: June 10, 1998

NADA 141-108 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: Etodolac
Trade Name: EtoGesic™
Indications for Use: Etodolac is recommended for the management of pain and inflammation associated with osteoarthritis in dogs
Date of Approval: July 22, 1998

NADA 141-108 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Etodolac
Trade Name: EtoGesic™
Effect of Supplement: This supplement allows for the addition of a 500 mg tablet.
Date of Approval: May 8, 2003

NADA 141-109 original approval
Sponsor: Roche Vitamins, Inc.
Generic Name: LASALOCID®, BACIFERM®
Trade Name: Lasalocid plus Bacitracin Zinc
Indications for Use: For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: April 15, 1999

NADA 141-110 original approval
Sponsor: Elanco Animal Health
Generic Name: Monesin, virginiamycin
Trade Name: Coban®, Stafac®
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: January 29, 1999

NADA 141-111 original approval
Sponsor: Pfizer Inc.
Generic Name: Carprofen
Trade Name: Rimadyl® chewable tablets
Indications for Use: Rimadyl® chewable tablets are indicated for the relief of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: May 14, 1999

NADA 141-111 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: Carprofen
Trade Name: Rimadyl® chewable tablets
Effect of Supplement: This supplement provides for flexibility in administration of the total daily dose of Rimadyl® Chewable Tablets. 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® chewable tablets are indicated for the relief of pain and inflamation associated with osteoarthritis in dogs.
Date of Approval: November 26, 2001

NADA 141-111 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: Carprofen
Trade Name: Rimadyl® Chewable Tablets
Effect of Supplement: For an additional claim for carprofen chewable tablets for the control of postoperative pain associated with soft tissue and orthopedic surgery in dogs.
Date of Approval: August 21, 2002

NADA 141-112 original approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin/nicarbazin Bacitracin methylene disalicylate Roxarsone
Trade Name: Maxiban®, BMD®, 3-Nitro®
Indications for Use: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; for increased rate of weight gain; improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: March 4, 1999

NADA 141-113 original approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly and Co.
Generic Name: Narasin/nicarbazin Roxarsone
Trade Name: Maxiban®, 3-Nitro®
Indications for Use: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain; improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: March 4, 1999

NADA 141-114 original approval
Sponsor: Pfizer, Inc.
Generic Name: Semduramicin, virginiamycin
Trade Name: Aviax™, Stafac®
Indications for Use: Provides for the combined use of two previously approved Type A Medicated Articles in the manufacture of Type C medicated feeds.
Date of Approval: July 27, 1999

NADA 141-120 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Clomipramine hydrochloride
Trade Name: Clomicalm ™ Tablets
Indications for Use: To be used apart of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
Date of Approval: December 10, 1998

NADA 141-120 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Clomipramine hydrochloride
Trade Name: CLOMICALM Tablets
Effect of Supplement: This supplement provides for the addition of a 5 mg tablet size.
Date of Approval: November 22, 2006

NADA 141-121 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin, bacitracin methylene disalicylate, roxarsone
Trade Name: BIO-COX® / BMD® / 3-NITRO®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler, roaster, and replacement (breeder and layer) in chickens not laying eggs.
Date of Approval: December 23, 1999

NADA 141-123 original approval
Sponsor: Merial Ltd.
Generic Name: Omeprazole
Trade Name: GastroGard ™
Indications for Use: For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
Date of Approval: March 16, 1999

NADA 141-124 original approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin, Nicarbazin, Bacitracin methylene disalicylate
Trade Name: Maxiban plus 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 as an aid in the control or prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
Date of Approval: January 14, 2002

NADA 141-129 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: Lasalocid, bambermycins
Trade Name: Avatec®, Flavomycin®
Indications for Use: For the combined use of two previously approved Type A Medicated Articles in the manufacture of Type C medicated feeds.
Date of Approval: August 6, 1999

NADA 141-135 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin, roxarsone
Trade Name: BIO-COX® / 3-NITRO®
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, improved feed efficiency, and improved pigmentation in roaster and replacement (breeder and layer) chickens not laying eggs.
Date of Approval: May 26, 2000

NADA 141-136 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin sodium, bacitracin methylene disalicylate
Trade Name: Bio-Cox® plus BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 20, 2000

NADA 141-138 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Bacitracin methylene disalicylate, Roxarsone
Trade Name: COBAN®, BMD®, 3-NITRO®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. runette, and E. mivati, as an aid in the prevention or control of necrotic enteritis caused or complicated by Clostridium spp. Or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens intended for use as cage layers.
Date of Approval: June 28 2000

NADA 141-139 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Roxarson
Trade Name: COBAN®, 3-NITRO
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens intended for use as cage layers.
Date of Approval: June 28 2000

NADA 141-140 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Bacitracin methylene disalicylate
Trade Name: COBAN®, BMD®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and for improved feed efficiency in replacement chickens intended for use as cage layers; As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin in broiler chickens and replacement chickens intended for use as cage layers.
Date of Approval: January 2, 2001

NADA 141-142 original approval
Sponsor: Alpharma, Inc.
Generic Name: Amprolium, Bacitracin methylene disalicylate, Roxarsone
Trade Name: AMPROL®, BMD®, 3-NITRO®
Indications for Use: For development of active immunity to coccidiosis, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.
Date of Approval: February 16, 2001

NADA 141-143 original approval
Sponsor: Norbrook Laboratories Limited
Generic Name: Oxytetracycline injection
Trade Name: TETRADURE 300 (Oxytetracycline) Injection (Rx product), OTC product: Oxytetracycline Injrection 300 mg/mL
Indications for Use: Beef and non-lactating dairy cattle, calves, including pre-ruminating (veal) calves: for the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus 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 staphylococcal and streptococcal organisms sensitive to oxytetracycline. Also, TETRADURE 300 is indicated (prescription use) for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica. Swine: for the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows, oxytetracycline 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: July 25, 2003

NADA 141-144 original approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate, fenbendazole
Trade Name: BMD® / SAFE-GUARD®
Indications for Use: Fenbendazole is indicated for the removal of:
Lungworms: adult (Metastrongylus apri, M. pudendotectus)
Gastrointestinal worms: adult and larvae (L3, L4 stages – liver, lung, and intestinal forms) large roundworms (Ascaris suum), adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum), small stomach worms (Hyostrongylus rubidus), adult and larvae (L2, L3, L4 stages – intestinal mucosal forms) whipworms (Trichuris suis)
Kidneyworms: adult and larvae (Stephanurus dentatus) Bacitracin methylene disalicylate is indicated for:
Increased rate of weight gain and improved feed efficiency in growing and finishing swine
Control of clostridial enteritis in suckling pigs caused by Clostridium perfringens when fed to pregnant sows during the period from 14 days before farrowing through 21 days after farrowing
Control of swine dysentery associated with Treponema hyodysenteriae in growing and finishing swine on premises with a history of swine dysentery but where signs of disease have not yet occurred or following an approved treatment of the disease
Date of Approval: April 7, 2000

NADA 141-146 original approval
Sponsor: Koffolk, Inc.
Generic Name: Nicarbazin, Bacitracin zinc
Trade Name: NICARB® BACIFERM®
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 and improved feed efficiency in broiler chickens.
Date of Approval: February 2, 2000

NADA 141-147 original approval
Sponsor: Alpharma, Inc
Generic Name: Decoquinate, chlortetracycline
Trade Name: Deccox® plus Chloromax®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: September 29, 2000

NADA 141-147 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: Decoquinate Chlortetracycline
Trade Name: DECCOX CHLORMAX
Effect of Supplement: To revise the Type B and C labeling with the revised decoquinate range of 12.9 to 90.8 g/ton and chlortetracycline range of 500 to 4000 g/ton in the Type C complete feed and decoquinate range of 90.9 to 535.7 g/ton and chlortetracycline range of 4000 to 20,000 g/ton in the Type C supplement feed.
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for the treatment of bacterial enteritis caused by Escherichia coli and for bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: December 16, 2004

NADA 141-148 original approval
Sponsor: Alpharma, Inc
Generic Name: decoquinate, monensin
Trade Name: DECCOX® RUMENSIN®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, and for increased feed efficiency in cattle being fed in confinement for slaughter.
Date of Approval: November 16, 2000

NADA 141-148 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: Decoquinate Monensin Sodium
Trade Name: DECCOX® / RUMENSIN®
Effect of Supplement: Provides for the expanded dose range of 12.9 to 90.8 grams per ton of feed for decoquinate when used in combination with monensin sodium, and for revised Blue Bird labels.
Date of Approval: July 30, 2004

NADA 141-149 original approval
Sponsor: Alpharma, Inc
Generic Name: decoquinate, monensin, tylosin
Trade Name: Deccox® Rumensin® Tylan®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis, and E. zuernii, for improved feed efficiency and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces pyogenes in growing-finishing cattle being fed in confinement for slaughter.
Date of Approval: November 16, 2000

NADA 141-150 original approval
Sponsor: Roche Vitamins, Inc.
Generic Name: Lasalocid, virginiamycin
Trade Name: Avatec®, Stafac®
Indications for Use: For the combined use of two previously approved Type A Medicated Articles in the manufacture of Type C medicated feeds.
Date of Approval: August 6, 1999

NADA 141-151 original approval
Sponsor: Pfizer, Inc.
Generic Name: Marbofloxacin
Trade Name: Zeniquin ™
Indications for Use: Zeniquin ™ (marbofloxacin) tablets are indicated for the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin.
Clinical effectiveness was confirmed in skin and soft tissue infections and urinary tract infections (cystitis) associated with bacteria susceptible to marbofloxacin.
Date of Approval: June 26, 1999

NADA 141-151 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Marbofloxacin
Trade Name: Zeniquin ™
Indications for Use: Provides for the use of Zeniquin (marbofloxacin) tablets in cats for the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin.
Date of Approval: August 1, 2001

NADA 141-152 original approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution ™
Indications for Use: Revolution kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations in dogs and cats. Revolution also is indicated for the treatment and control of sarcoptic mange (Sarcoptes scabiei) in dogs, and the treatment of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections in cats. Revolution is recommended for use in dogs and cats six weeks of age and older.
Date of Approval: May 26, 1999

NADA 141-152 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution ™
Effect of Supplement: Provides for the additional indication for control of tick infestations in dogs
Date of Approval: August 5, 1999

NADA 141-152 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution ™
Effect of Supplement: Provide additional indication for control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm(Toxocara cati) infections in cats.
Date of Approval: June 13, 2000

NADA 141-153 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bacitracin methylene disalicylate
Trade Name: Clinacox ™, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, 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. For increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: January 13, 2000

NADA 141-154 original approval
Sponsor: Alpharma, Inc.
Generic Name: Robenidine hydrochloride, Bacitracin methylene disalicylate
Trade Name: Robenz® plus BMD®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the control or prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
Date of Approval: February 11, 2002

NADA 141-155 original approval
Sponsor: Alpharma, Inc.
Generic Name: Robenidine hydrochloride, Bacitracin methylene disalicylate, Roxarsone
Trade Name: Robenz®, BMD®, 3-Nitro®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens; .
Date of Approval: July 3, 2000

NADA 141-156 original approval
Sponsor: Alpharma, Inc.
Generic Name: Amprolium, Bacitracin methylene disalicylate
Trade Name: AMPROL®, BMD®
Indications for Use: For the development of active immunity to coccidiosis, and for increased rate of weight gain and improved feed efficiency in replacement chickens.
Date of Approval: February 12, 2001

NADA 141-157 original approval
Sponsor: Alpharma, Inc.
Generic Name: Halofuginone hydrobromide, roxarsone
Trade Name: Stenorol® / 3-Nitro®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati (E. mitis), and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in chickens not laying eggs.
Date of Approval: July 3, 2000

NADA 141-158 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril Bambermycins
Trade Name: Clinacox ™; Flavomycin®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati (E. mitis). 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. For increased rate weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 3, 2000