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U.S. Department of Health and Human Services

Animal & Veterinary

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141-251 to 200-120

NADA 141-251 original approval
Sponsor: Bayer HealthCare LLC
Generic Name: imidacloprid and moxidectin
Trade Name: Advantage Multi® for Dogs
Indications for Use: ADVANTAGE MULTI for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. ADVANTAGE MULTI for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). ADVANTAGE MULTI for Dogs is also indicated for the treatment and control of the following intestinal parasites:
Date of Approval: December 20, 2006 

NADA 141-251 supplemental approval
Sponsor: Bayer HealthCare LLC, Animal Health Division
Generic Name: Imidacloprid and Moxidectin
Trade Name: Advantage Multi® for Dogs
Indications for Use: This supplement provides for the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs and the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis.
Date of Approval: October 24, 2013 

NADA 141-253 original approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: EQUIOXX Oral Paste
Indications for Use: EQUIOXX Oral Paste is administered for up to 14 days for the control of pain and inflammation associated with osteoarthritis in horses.
Date of Approval: December 30, 2005

NADA 141-254 original approval
Sponsor: Bayer HealthCare LLC
Generic Name: imidacloprid + moxidectin
Trade Name: ADVANTAGE MULTI for Cats
Indications for Use: ADVANTAGE MULTI for Cats is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. ADVANTAGE MULTI for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. ADVANTAGE MULTI for Cats is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites:
Date of Approval: January 19, 2007

NADA 141-254 supplemental approval
Sponsor: Bayer HealthCare LLC, Animal Health Division
Generic Name: Imidacloprid and Moxidectin
Trade Name: Advantage Multi® for Cats
Indications for Use: This supplement provides for the prevention of heartworm disease in ferrets caused by Dirofilaria immitis; kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations on ferrets.
Date of Approval: October 31, 2013

NADA 141-255 original approval
Sponsor: Eka Chemicals, Inc.
Generic Name: Hydrogen peroxide Liquid solution
Trade Name: 35% PEROX-AID
Indications for Use: For the control of mortality in freshwater-reared finfish eggs due to saprolegniasis. For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacteriurn branchiophilum. And for the control of mortality in freshwater-reared coolwater finfish and channel catfish due to external colurnnaris disease associated with Flavobacterium columnare (Flexibacler columnaris)."
Date of Approval: January 11, 2007

NADA 141-257 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin, pyrantel pamoate, praziquantel
Trade Name: IVERHART MAX Chewable Tablets
Indications for Use: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworms (Dipylidium caninum, Taenia pisiformis).
Date of Approval: October 13, 2006

NADA 141-257 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin, pyrantel pamoate, praziquantel
Trade Name: IVERHEART MAX Chewable Tablets
Effect of Supplement: This supplement provides for removal of the following statement from the Precautions section of the package insert: “The effective use of this drug for the treatment and control of tapeworms has not been evaluated in dogs less than 15 pounds.”
Date of Approval: February 15, 2007

NADA 141-258 original approval
Sponsor: Intervet, Inc.
Generic Name: Zilpaterol hydrochloride
Trade Name: Zilmax®
Indications for Use: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed.
Date of Approval: August 10, 2006

NADA 141-258 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Zilpaterol hydrochloride
Trade Name: Zilmax®
Indications for Use: This supplement provides for: 1) component feeding of 60 mg zilpaterol hydrochloride/head/day for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed, and 2) adding the following statement to the labeling for the use of zilpaterol hydrochloride in complete feed: “CAUTION: Not to be fed to cattle in excess of 90 mg/head/day in complete feed. If pen consumption of complete feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be fed in complete feed.”.
Date of Approval: October 30, 2014

NADA 141-259 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: AQUAFLOR-CA1
Indications for Use: For the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare.
Date of Approval: April 13, 2007

NADA 141-260 original approval
Sponsor: Pfizer, Inc.
Generic Name: Dirlotapide
Trade Name: SLENTROL
Indications for Use: For the management of obesity in dogs
Date of Approval: December 12, 2006

NADA 141-261 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Pyrantel pamoate /Praziquantel
Trade Name: WORMXPLUS* Flavored Chewables VIRBANTEL Flavored Chewables
Indications for Use: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocephala); and tapeworms (Dipylidium caninum, Taenia pisiformis) in dogs and puppies.
Date of Approval: March 13, 2007

NADA 141-262 original approval
Sponsor: Pfizer, Inc.
Generic Name: Maropitant citrate
Trade Name: CERENIA Tablets
Indications for Use: For the prevention of acute vomiting in dogs. For the prevention of vomiting due to motion sickness in dogs
Date of Approval: January 29, 2007

NADA 141-263 original approval
Sponsor: Pfizer, Inc.
Generic Name: Maropitant citrate
Trade Name: CERENIA Injectable Solution
Indications for Use: For the prevention and treatment of acute vomiting in dogs.
Date of Approval: January 29, 2007

NADA 141-263 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Maropitant citrate
Trade Name: Cerenia® Injectable Solution
Effect of Supplement: This supplement provides for the additional indication, “for the treatment of vomiting in cats.”
Date of Approval: May 16, 2012

NADA 141-263 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Maropitant citrate
Trade Name: Cerenia® Injectable Solution
Indications for Use: This supplement provides for the decrease in the minimum age to “for use in dogs 8 weeks and older” for the prevention and treatment of acute vomiting in dogs.
Date of Approval: May 16, 2012

NADA 141-264 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: NUFLOR (florfenicol), An Antibiotic
Indications for Use: For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.
Date of Approval: November 3, 2006

NADA 141-265 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol (with 2-pyrrolidone and triacetin)
Trade Name: NUFLOR GOLD Injectable Solution
Indications for Use: NUFLOR GOLD Injectable Solution is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.
Date of Approval: March 21, 2008

NADA 141-265 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Florfenicol (in 2-pyrrolidone and triacetin)
Trade Name:  NUFLOR GOLD
Effect of Supplement: This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the BRD treatment indication.
Date of Approval: September 4, 2009

NADA 141-266 original approval
Sponsor: Intervet Schering-Plough Animal Health
Generic Name: Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole
Trade Name: POSATEX
Indications for Use: POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).
Date of Approval: February 18, 2010

NADA 141-267 original approval
Sponsor: Orion Corporation
Generic Name: dexmedetomidine hydrochloride
Trade Name: DEXDOMITOR
Indications for Use: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. DEXDOMITOR is also indicated for use as a preanesthetic to general anesthesia
Date of Approval: December 1, 2006

NADA 141-267 supplemental approval
Sponsor: Orion Corp.
Generic Name: dexmedetomidine hydrochloride
Trade Name: DEXDOMITOR
Effect of Supplement: The effect of the supplement is to add an indication for its use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures in cats.
Date of Approval: September 7, 2007

NADA 141-268 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Diclazuril
Trade Name: PROTAZIL Antiprotozoal Pellets
Indications for Use: PROTAZIL Antiprotozoal Pellets are indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses.
Date of Approval: March 29, 2007

NADA 141-269 original approval
Sponsor: Intervet Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: REVALOR-XS
Indications for Use: A slow-release delivery system which increases rate of weight gain and improves feed efficiency for up to 200 days in steers fed in confinement for slaughter.
Date of Approval: January 19, 2007

NADA 141-272 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: fluoxetine hydrochloride
Trade Name: RECONCILE
Indications for Use: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Date of Approval: January 19, 2007

NADA 141-273 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Pimobendan
Trade Name: VETMEDIN
Indications for Use: VETMEDIN (pimobendan) is indicated for the management of the signs of mild, moderate, or severe (modified NYHA Class IIa, IIIb, or IVc) congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI) or dilated cardiomyopathy (DCM). VETMEDIN is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
a A dog with modified New York Heart Association (NYHA) Class II heart failure has fatigue, shortness of breath, coughing, etc. apparent when ordinary exercise is exceeded.
b A dog with modified NYHA Class III heart failure is comfortable at rest, but exercise capacity is minimal.
c A dog with modified NYHA Class IV heart failure has no capacity for exercise and disabling clinical signs are present even at rest.
Date of Approval: April 30, 2007

NADA 141-274 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: etodolac
Trade Name: ETOGESIC Injectable
Indications for Use: ETOGESIC Injectable is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: September 7, 2007

NADA 141-275 original approval
Sponsor: Bayer HealthCare LLC
Generic Name: emodepside / praziquantel
Trade Name: PROFENDER Topical Solution
Indications for Use: PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.
Date of Approval: June 29, 2007

NADA 141-276 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride, monensin USP, and tylosin phosphate
Trade Name: ZILMAX plus RUMENSIN plus TYLAN
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: January 10, 2008

NADA 141-277 original approval
Sponsor: Elanco Animal Health
Generic Name: Spinosad
Trade Name: COMFORTIS
Indications for Use: Kill fleas and are indicated for the prevention and treatment of flea infestations (Ctenocephalides felis) on dogs for one month.
Date of Approval: September 25, 2007

NADA 141-277 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Spinosad
Trade Name: Comfortis®
Effect of Supplement: 1) To add an indication for use in cats: Kills fleas and is indicated for the prevention and treatment of flea infestations (Ctenocephalides felis) for one month in cats and kittens 14 weeks of age and older, and two pounds of body weight or greater, and 2) add the 90 mg dose band for use of Comfortis® in dogs.
Date of Approval: August 20, 2012

NADA 141-278 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride and monensin USP
Trade Name: ZILMAX plus RUMENSIN
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: February 15, 2008

NADA 141-279 original approval
Sponsor: Alpharma Inc.
Generic Name: Nicarbazin and Bacitracin Methylene Disalicylate
Trade Name: NICARB plus BMD
Indications for Use: Nicarbazin (113.5 g/ton) and bacitracin methylene disalicylate (50 g/ton) - As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix and E. brunetti) coccidiosis 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.
Nicarbazin (113.5 g/ton) and bacitracin methylene disalicylate (4 to 50 g/ton) - 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 21, 2008

NADA 141-280 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate
Trade Name: ZILMAX plus RUMENSIN plus TYLAN plus MGA
Indications for Use: For increased rate of weight gain, increased carcass leanness, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: February 29, 2008

NADA 141-281 original approval
Sponsor: Phibro Animal Health
Generic Name: Semduramicin
Trade Name: AVIAX II
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis
Date of Approval: December 7, 2007

NADA 141-282 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride, monensin USP, and melengestrol acetate
Trade Name: ZILMAX plus RUMENSIN plus MGA
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: February 22, 2008

NADA 141-284 original approval
Sponsor: Intervert Inc.
Generic Name: Zilpaterol hydrochloride and melengestrol acetate
Trade Name: ZILMAX plus MGA
Indications for Use: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: February 29, 2008

NADA 141-285 original approval
Sponsor: Pfizer, Inc.
Generic Name: Cefovecin sodium
Trade Name: CONVENIA
Indications for Use: For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida.
Date of Approval: April 25, 2008

NADA 141-286 original approval
Sponsor: Intervet Inc.
Generic Name: Fenbendazole/ivermectin/praziquantel
Trade Name: PANACUR Plus Soft Chews
Indications for Use: For the treatment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs.
Date of Approval: May 9, 2008

NADA 141-288 original approval
Sponsor: Pharmacia & Upjohn Co., a Division of Pfizer, Inc.
Generic Name: Ceftiofur hydrochloride
Trade Name: EXCENEL RTU EZ Sterile Suspension
Indications for Use: For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis, and Streptococcus suis.
For treatment of the following bacterial diseases in cattle:  1) bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni; 2) acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and 3) acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Date of Approval: July 1, 2008

NADA 141-288 supplemental approval
Sponsor: Zoetis Inc.
Generic Name: Ceftiofur hydrochloride
Trade Name: EXCENEL® RTU EZ
Indications for Use: This supplement provides for a reformulated product for use in swine and cattle, addition of a new route of administration (intramuscular injection) in cattle, change of withdrawal period in cattle, and a 250 mL vial size.
Date of Approval: September 13, 2013

NADA 141-289 original approval
Sponsor: Phibro Animal Health
Generic Name:
Semduramicin sodium biomass and Virginiamycin
Trade Name:
AVIAX II plus STAFAC
Indications for Use: 
Semduramicin sodium biomass – 22.7 g/ton and virginiamycin – 5 g/ton - for the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis, for increased rate of weight gain and improved feed efficiency in broiler chickens.
Semduramicin sodium biomass – 22.7 g/ton and virginiamycin – 5 – 15 g/ton - for the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis, and for increased rate of weight gain in broiler chickens.
Semduramicin sodium biomass – 22.7 g/ton and virginiamycin – 20 g/ton - for the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis, and prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin in broiler chickens.
Date of Approval: July 13, 2009
 

NADA 141-290 original approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: TOPMAX 9
Indications for Use: For increased rate of weight gain and improved feed efficiency in finishing tom turkeys and hen turkeys fed for the last 14 days prior to slaughter.
Date of Approval: November 12, 2008

NADA 141-291 original approval
Sponsor: Dechra, Ltd
Generic Name: Trilostane
Trade Name: VETORYL
Indications for Use:
For the treatment of pituitary-dependent hyperadrenocorticism in dogs and for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs.
Date of Approval: December 5, 2008

NADA 141-291 supplemental approval
Sponsor:
 Dechra, Ltd
Generic Name:  Trilostane
Trade Name:  VETORYL
Effect of Supplement:  This supplement provides for the addition of a 10 mg capsule size.
Date of Approval:  June 5, 2009

NADA 141-292 original approval
Sponsor: Dechra, Ltd.
Generic Name:  methimazole
Trade Name:  Felimazole Coated Tablets
Indications for Use:  For the treatment of hyperthyroidism in cats.
Date of Approval:  May 27, 2009

NADA 141-293 original approval
Sponsor
: Alpharma Inc.
Generic Name: Lasalocid sodium plus Roxarsone
Trade Name: AVATEC plus 3-NITRO
Indications for Use: For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides, for increased rate of weight gain, improved feed efficiency and improved pigmentation in growing turkeys.
Date of Approval: May 22, 2009

NADA 141-294 original approval
Sponsor: GTC Biotherapeutics, Inc.
Generic Name: Bc6 rDNA construct in GTC 155-92 Goats
Trade Name: Bc6 rDNA construct in GTC 155-92 Goats
Indications for Use: Expression of the human gene for antithrombin (which is intended for the treatment of humans) in the mammary gland
Date of Approval: February 6, 2009

NADA 141-295 original approval
Sponsor:  Pharmacia & Upjohn Company, a Division of Pfizer Inc.
Generic Name:  Toceranib phosphate
Trade Name:  Palladia
Indications for Use:
 For the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.
Date of Approval:  May 22, 2009

NADA 141-297 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Protamine zinc recombinant human insulin
Trade Name: PROZINC
Indications for Use: For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.
Approval Date: October 28, 2009

NADA 141-298 original approval
Sponsor: Janssen Pharmaceutica NV
Generic Name: miconazole nitrate, polymyxin B sulfate, prednisolone acetate
Trade Name: SUROLAN otic suspension
Indications for Use: For the treatment of canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius)
Date of Approval: November 23, 2009

NADA 141-299 original approval
Sponsor:
Intervet, Inc.
Generic Name:
Florfenicol and flunixin meglumine (in 2‑pyrrolidone and triacetin)
Trade Name:
Resflor Gold
Indications for Use:
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and control of BRD-associated pyrexia in beef and non‑lactating dairy cattle.
Date of Approval: November 23, 2009

NADA 141-299 supplemental approval
Sponsor: Intervet, Inc.
Generic Name:
Florfenicol and flunixin meglumine (in 2‑pyrrolidone and triacetin)
Trade Name:
Resflor Gold
Indications for Use:
This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the treatment of BRD and control of BRD-associated pyrexia indication.
Date of Approval: June 7, 2010

NADA 141-301 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride and monensin, USP
Trade Name: TOPMAX plus COBAN
Indications for Use: Ractopamine hydrochloride 4.6 to 11.8 g/ton and monensin, USP 54 to 90 g/ton: For increased rate of weight gain and improved feed efficiency in finishing tom turkeys fed for the last 14 days prior to slaughter, and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.
Ractopamine hydrochloride 4.6 to 11.8 g/ton and monensin, USP 54 to 90 g/ton: For increased rate of weight gain and improved feed efficiency in finishing hen turkeys fed for the last 7 to 14 days prior to slaughter, and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.
Date of Approval: December 12, 2009

NADA 141-302 original approval
Sponsor:  Pharmacia & Upjohn Company, A Division of Pfizer Inc.
Generic Name:  Progesterone
Trade Name:  
EAZI-BREED CIDR Sheep Insert
Indications for Use:
For induction of estrus in ewes (sheep) during seasonal anestrus.
Date of Approval: October 1, 2009

NADA 141-303 original approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc.
Generic Name: propofol
Trade Name: Propoclear
Indications for Use: For the induction and maintenance of anesthesia and for induction followed by maintenance with an inhalant anesthetic, in cats and dogs.
Date of Approval: May 21, 2010
 

NADA 141-305 original approval
Sponsor: Intervet, Inc.
Generic Name:
Orbifloxacin
Trade Name: ORBAX Oral Suspension
Indications for Use:
For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Pasteurella multocida.
Date of Approval: March 25, 2010

NADA 141-306 original approval
Sponsor: Orion Corporation
Generic Name:
Detomidine hydrochloride
Trade Name:
DORMOSEDAN GEL
Indications for Use:
DORMOSEDAN GEL is indicated for sedation and restraint in horses.
Date of Approval:
March 22, 2010

Conditionally Approved, Application 141-308 original
Sponsor: AB Science
Generic Name:
Masitinib mesylate
Trade Name:
Kinavet®-CA1
Indications for Use:
For the treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids.
Date of Approval: 
December 15, 2010

Conditionally Approved, Application 141-308 supplemental
Sponsor: AB Science
Generic Name:
Masitinib mesylate
Trade Name:
Kinavet®-CA1
Effect of Supplement:
This supplement provides for a revised indication to reflect the new designation for Kinavet® CA1. The effect of the supplement is the removal of the recurrent (post-surgery) population from the indication.
Date of Approval: 
January 30, 2012

NADA 141-312 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name:
Oxytetracycline and flunixin meglumine
Trade Name:
Hexasol™ Injection
Indications for Use:
For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and non-lactating dairy cattle.
Date of Approval:
November 29, 2010

NADA 141-313 original approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: EQUIOXX Injection
Indications for Use: For the control of pain and inflammation associated with osteoarthritis in horses.
Date of Approval: August 20, 2010

NADA 141-314 original approval
Sponsor: Dechra, Ltd.
Generic Name: Domperidone
Trade Name: EQUIDONE Gel
Indications for Use: For the prevention of fescue toxicosis in periparturient mares
Date of Approval: September 9, 2010
 

NADA 141-319 original approval
Sponsor: Thorn BioScience LLC.
Generic Name: Deslorelin acetate
Trade Name: SucroMate™ Equine
Indications for Use: For inducing ovulation within 48 hours of treatment in cyclic estrous mares with an ovarian follicle between 30 and 40 mm in diameter.
Date of Approval: November 5, 2010

NADA 141-320 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Robenacoxib
Trade Name: ONSIOR
Indications for Use: ONSIOR tablets are indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats > 5.5 lbs (2.5 kg) and > 6 months of age; for up to a maximum of 3 days.
Date of Approval: March 8, 2011

NADA 141-320 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Robenacoxib
Trade Name: Onsior® tablets
Indications for Use: This supplement provides for lowering the age limit to > 4 months of age. All cats should still meet the minimum weight requirement of 5.5 lbs (2.5 kg).
Date of Approval: December 9, 2013
 

NADA 141-321 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Spinosad and milbemycin oxime
Trade Name: Trifexis™
Indications for Use: Indicated for the prevention of heartworm disease (Dirofilaria immitis). Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), and the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina) and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.
Date of Approval:  January 4, 2011
 

NADA 141-322 original approval
Sponsor: Pfizer, Inc.
Generic Name: Gonadotropin Releasing Factor – Diphtheria Toxoid conjugate (GnRF-DT conjugate)
Trade Name: Improvest®
Indications for Use: For the temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.
Date of Approval:  March 22, 2011
 

NADA 141-322 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Gonadotropin Releasing Factor – Diphtheria Toxoid conjugate (GnRF-DT conjugate)
Trade Name: Improvest®
Indications for Use: The supplemental NADA extends the slaughter interval from 4 to 8 weeks after the second dose to 3 to 10 weeks..
Date of Approval:  November 30, 2011

NADA 141-324 original approval
Sponsor: Pegasus Laboratories, Inc.
Generic Name: phenylpropanolamine hydrochloride
Trade Name: PROIN Chewable Tablets
Indications for Use:  For the control of urinary incontinence due to urethral sphincter hypotonus in dogs.
Date of Approval: August 4, 2011

NADA 141-325 original approval
Sponsor: Intervet Inc.
Generic Name: Estriol
Trade Name: INCURIN
Indications for Use: For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.
Date of Approval: July 25, 2011

NADA 141-326 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Cephalexin
Trade Name: Rilexine® Chewable Tablets
Indications for Use: For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.
Date of Approval: June 16, 2012

NADA 141-327 original approval
Sponsor: Merial Ltd.
Generic Name: Eprinomectin
Trade Name: LONGRANGE™
Indications for Use: For the treatment and control of the following parasites:
 Gastrointestinal Roundworms
 Cooperia oncophora – Adults and L4
 Cooperia punctata – Adults and L4
 Cooperia surnabada – Adults and L4
 Haemonchus placei – Adults
 Oesophagostomum radiatum – Adults
 Ostertagia lyrata – Adults
 Ostertagia ostertagi – Adults, L4, and inhibited L4
 Trichostrongylus axei – Adults and L4
 Trichostrongylus colubriformis – Adults
 Lungworms
 Dictyocaulus viviparus – Adults
 Grubs
 Hypoderma bovis
 Mites
 Sarcoptes scabiei var. bovis

Persistent Activity
LONGRANGE™ (eprinomectin) has been proven to effectively protect cattle from reinfection with the following parasites for the indicated amounts of time following treatment:
Parasites -  Duration of Persistent Effectiveness
Gastrointestinal Roundworms 
Cooperia oncophora - 100 days
Cooperia punctata - 100 days
Haemonchus placei - 120 days
Oesophagostomum radiatum - 120 days
Ostertagia lyrata - 120 days
Ostertagia ostertagi - 120 days
Trichostrongylus axei - 100 days
Lungworms
Dictyocaulus viviparous - 150 days
Date of Approval: September 26, 2011

NADA 141-327 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Eprinomectin
Trade Name: LONGRANGE™
Indications for Use:This supplement provides for the approval of a new indication for the treatment and control of Bunostomum phlebotomum (adults and L4s) and for the protection of cattle from reinfection with Bunostomum phlebotomum for 150 days following treatment.
Date of Approval: April 16, 2014

NADA 141-328 original approval
Sponsor: Merial Ltd.
Generic Name: Gamithromycin
Trade Name: Zactran®
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.
For the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica and Pasteurella multocida.
Date of Approval: June 16, 2011

NADA 141-328 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Gamithromycin
Trade Name: Zactran®
Effect of Supplement: This supplemental application provides for the addition of the treatment of bovine respiratory disease (BRD) associated with M. bovis in beef and non-lactating dairy cattle.
Date of Approval: February 8, 2012

NADA 141-329 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Cyclosporine oral solution, USP MODIFIED
Trade Name: Atopica®
Indications for Use: Atopica® for Cats is indicated for the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), military dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight.
Date of Approval: August 8, 2011

NADA 141-330 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Hydrocortisone aceponate, miconazole nitrate, gentamicin sulfate
Trade Name: Easotic®
Indications for Use: Easotic® suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
Date of Approval: October 31, 2011

NADA 141-331 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Pergolide mesylate
Trade Name: Prascend®
Indications for Use: For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing’s Disease) in horses.
Date of Approval: September 7, 2011

NADA 141-333 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin oxime, lufenuron, and praziquantel
Trade Name: Sentinel® Spectrum®
Indications for Use: For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations (Ctenocephalides felis); and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.
Date of Approval: December 8, 2011
 

NADA 141-334 original approval
Sponsor: Intervet, Inc.
Generic Name: Tildipirosin
Trade Name: Zuprevo™
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle, and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
Date of Approval: May 14, 2012

NADA 141-336 original approval
Sponsor: ECO LLC
Generic Name: Tylvalosin tartrate
Trade Name: Aivlosin®
Indications for Use: Control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.
Date of Approval: July 6, 2012

NADA 141-337 original approval
Sponsor: Nexcyon Pharmaceuticals, Inc.
Generic Name: Fentanyl
Trade Name: RECUVYRA
Indications for Use: For the control of postoperative pain associated with surgical procedures in dogs.
Date of Approval: June 23, 2012 

NADA 141-338 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin oxime/praziquantel
Trade Name: Interceptor® Spectrum®
Indications for Use: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.
Date of Approval: June 16, 2012

NADA 141-339 original approval
Sponsor: JBS United Animal Health II LLC
Generic Name: Triptorelin acetate
Trade Name: OvuGel™
Indications for Use: For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.
Date of Approval: September 18, 2012 

NADA 141-340 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin
Trade Name: Skycis™ 100
Indications for Use: 1) For increased rate of weight gain in growing-finishing swine when fed for at least 4 weeks.
2) For increased rate of weight gain and improved feed efficiency in growing-finishing swine when fed for at least 4 weeks.
Date of Approval: September 5, 2012

NADA 141-342 original approval
Sponsor: Jurox Pty. Ltd.
Generic Name: Alfaxalone
Trade Name: Alfaxan®
Indications for Use: For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in cats and dogs.
Date of Approval: September 6, 2012

NADA 141-342 supplemental approval
Sponsor: Jurox Pty. Ltd.
Generic Name: Alfaxalone
Trade Name: Alfaxan®
Indications for Use:This supplement provides for the approval of the revised labeling components to reflect the placement of alfaxalone into Schedule IV controlled substance classification..
Date of Approval: August 1, 2014

NADA 141-343 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Tilmicosin phosphate and monensin
Trade Name: Pulmotil® 90 and Rumensin® 90
Indications for Use: 1) For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.
2) For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.
Date of Approval: August 1, 2012

NADA 141-344 original approval
Sponsor: Bayer HealthCare LLC, Animal Health Division
Generic Name: Pradofloxacin
Trade Name: Veraflox® Oral Suspension for Cats
Indications for Use: For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius.
Date of Approval: November 7, 2012

NADA 141-345 original approval
Sponsor: Zoetis, Inc.
Generic Name: Oclacitinib
Trade Name: Apoquel®
Indications for Use:Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Date of Approval: May 14, 2013

NADA 141-346 original approval
Sponsor: Abbott Laboratories
Generic Name: Meloxicam
Trade Name: OroCAM™
Indications for Use: For the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: November 2, 2012

NADA 141-348 original approval
Sponsor: Zoetis, Inc.
Generic Name: Trenbolone acetate and estradiol benzoate
Trade Name: SYNOVEX® ONE FEEDLOT, SYNOVEX® ONE GRASS
Indications for Use: SYNOVEX® ONE FEEDLOT: For increased rate of weight gain and improved feed efficiency for up to 200 days in steers and heifers fed in confinement for slaughter.
SYNOVEX® ONE GRASS: For increased rate of weight gain for up to 200 days in pasture steers and heifers (slaughter, stocker and feeder).
Date of Approval: July 31, 2014

NADA 141-349 original approval
Sponsor: Zoetis, Inc.
Generic Name: Tulathromycin
Trade Name: Draxxin® 25 Injectable Solution
Indications for Use: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with A. pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs where SRD has been diagnosed.
Date of Approval: July 9, 2013

NADA 141-360 original approval
Sponsor: Aurora Pharmaceutical, LLC
Generic Name: Sulfadiazine/Trimethoprim
Trade Name: EQUISUL-SDT®
Indications for Use: For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.
Date of Approval: July 26, 2013

NADA 141-361 original approval
Sponsor: Elanco Animal Health a Division of Eli Lilly & Co.
Generic Name: Tilmicosin phosphate
Trade Name: Pulmotil® AC
Indications for Use: For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
Date of Approval: February 13, 2014

NADA 141-406 original approval
Sponsor: Merial Ltd.
Generic Name: Afoxolaner
Trade Name: NexGard™
Indications for Use: For the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of American dog tick (Dermacentor variabilis) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month.
Date of Approval: September 14, 2013

NADA 141-406 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Afoxolaner
Trade Name: NexGard™
Indications for Use: The effect of the supplement is to add language to the Effectiveness section of the package insert from the flea speed of kill study.
Date of Approval: April 1, 2014

NADA 141-406 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Afoxolaner
Trade Name: NexGard™
Indications for Use: This supplement provides for the treatment and control of Black-legged tick (Ixodes scapularis) and Lone Star tick (Amblyomma americanum) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month.
Date of Approval: May 15, 2014

NADA 141-419 original approval
Sponsor: Huvepharma AD
Generic Name: Clopidol and bambermycins
Trade Name: Coyden® 25 and Flavomycin®
Indications for Use: As an aid in 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: December 19, 2013

NADA 141-420 original approval
Sponsor: Ceva Sante Animale
Generic Name: Tiludronate disodium
Trade Name: Tildren®
Indications for Use: For the control of clinical signs associated with navicular syndrome in horses.
Date of Approval: February 13, 2014

NADA 141-421 original approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin/praziquantel
Trade Name: Duocare™
Indications for Use: For the treatment and control of the following parasites in horses over 5 months of age:
Tapeworms Anoplocephala perfoliata; Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus; Cylicodontophorus spp. Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum; Small Strongyles - Fourth-stage larvae; Pinworms (adults and fourth-stage larvae)- Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Date of Approval: May 12, 2014

Conditionally Approved, Application 141-422 original approval
Sponsor: Oasmia Pharmaceutical AB
Generic Name: Paclitaxel
Trade Name: Paccal Vet®-CA1
Indications for Use: For the treatment of nonresectable stage III, IV or V mammary carcinoma in dogs that have not received previous chemotherapy or radiotherapy. For the treatment of resectable and nonresectable squamous cell carcinoma in dogs that have not received previous chemotherapy or radiotherapy.
Date of Approval: February 27, 2014

NADA 141-423 original approval
Sponsor: Axcentive SARL
Generic Name: Chloramine-T trihydrate
Trade Name: HALAMID® AQUA
Indications for Use: For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium spp.
For the control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare.
For the control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare.
Date of Approval: April 30, 2014

NADA 141-426 original approval
Sponsor: Intervet, Inc.
Generic Name: Fluralaner
Trade Name: Bravecto™
Indications for Use: Bravecto™ kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.
Bravecto™ is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.
Date of Approval: May 15, 2014

NADA 141-427 original approval
Sponsor: Dechra, Ltd.
Generic Name: Clodronate injection
Trade Name: OSPHOS
Indications for Use: For the control of clinical signs associated with navicular syndrome in horses.
Date of Approval: April 28, 2014

NADA 141-431 original approval
Sponsor: Bioniche Animal Health USA, Inc.
Generic Name: Porcine pituitary-derived follicle stimulating hormone
Trade Name: FOLLTROPIN®
Indications for Use: For the induction of superovulation in beef and dairy heifers and cows.
Date of Approval: July 13, 2014

 

NADA 141-434 original approval
Sponsor: Abbott Laboratories
Generic Name: Buprenorphine
Trade Name: Simbadol™
Indications for Use: For the control of postoperative pain associated with surgical procedures in cats.
Date of Approval: July 18, 2014
 

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

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

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

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

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

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

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

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

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

ANADA 200-026 supplemental approval
Sponsor: PennField Oil Company
Generic Name: Oxytetracycline hydrochloride
Trade Name: Pennox™ 343
Effect of Supplement: This supplement provides for the addition of new species (finfish and honey bees) and their corresponding indications to all labeling components.
Date of Approval: December 6, 2010

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

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

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

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

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

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

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

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

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

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

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

ANADA 200-046 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Sulfate Soluble Powder 325 g/lb
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats.
Date of Approval: April 03, 1996

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

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

ANADA 200-050 supplemental approval
Sponsor: Rhone-Merieux, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats.
Date of Approval: April 03, 1996

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

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

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

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

ANADA 200-061 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Flunixin meglumine
Trade Name: Flu-Nix™
Indications for Use: This supplement provides for a change in proprietary name and the addition of the lactating dairy cattle indication, “For the control of pyrexia associated with acute bovine mastitis.”
Date of Approval: September 27, 2010

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

ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline HCl
Trade Name: AGRIMYCIN® 343 SOLUBLE POWDER
Effect of Supplement: Revised withdrawal period for turkeys and swine.Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).Based upon the formulation characteristics of the genetic product, Agri Laboratories Ltd. was granted a waiver from conducting an in vivo bioequivalence study for Oxytetracycline HCl Soluble Powder. The genetic and pioneer products contain the same active ingredient and are water soluble powders administered as oral solutions. The genetic product contains no inactive ingredients that may significantly affect the absorption of the active ingredient.
Date of Approval: October 04, 2001

ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Agrimycin® 166
Effect of Supplement: The supplement provides for approval of an additional packet size, 9.87 oz [280 g], a different trade name, an alternate concentration of active ingredient and a change in the inactive ingredients in the finished dosage form.
Date of Approval: June 30, 2004

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

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

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

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

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

ANADA 200-075 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium
Trade Name: Sacox®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati
Date of Approval: February 23, 1994

ANADA 200-075 supplemental approval
Sponsor: Intervet Inc.
Generic Name: salinomycin sodium
Trade Name: Sacox®
Indications for Use: To add roaster and replacement (breeder and layer) chickens to the label claim for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and to add quail to the label claim for the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae.
Date of Approval: November 8, 2002

ANADA 200-080 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: Salinomycin sodium, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Bambermycins
Trade Name: Sacox, 3-Nitro, Roxarsone, Flavomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: March 8, 1994

ANADA 200-081 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin methylene disalicylate
Trade Name: Sacox, 3-Nitro, BMD
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for increased rate of weight gain.
Date of Approval: March 4, 1994

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

ANADA 200-083 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bambermycins
Trade Name: Sacox, Flavomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , and for improved feed efficiency.
Date of Approval: March 18, 1994

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

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

ANADA 200-089 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bacitracin zinc
Trade Name: Sacox, Baciferm
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain.
Date of Approval: April 6, 1994

ANADA 200-090 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), lincomycin
Trade Name: Sacox, 3-Nitro, Lincomix
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994

ANADA 200-091 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex/roxarsone
Trade Name: Sacox and 3-Nitro and Aureomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994

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

ANADA 200-093 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, lincomycin
Trade Name: Sacox Lincomix
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency.
Date of Approval: April 6, 1994

ANADA 200-094 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone, virginiamycin
Trade Name: Sacox 3-Nitro Stafac
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994

ANADA 200-095 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex
Trade Name: Sacox and Aureomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti ,and E. mivati , and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994

ANADA 200-096 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/oxytetracycline
Trade Name: Sacox and Terramycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti , and E. mivati , and as an aid in the reduction of mortality due to airsacculitis (air sac infection) caused by Escherichia coli infections sensitive to oxytetracycline.
Date of Approval: November 25, 1994

ANADA 200-097 original approval
Sponsor: Hoechst-Roussel Agri Vet Company
Generic Name: salinomycin sodium, roxarsone
Trade Name: Sacox 3-Nitro
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency.
Date of Approval: April 6, 1994

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

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

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

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

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

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

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

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

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

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

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