Animal & Veterinary
141-251 to 200-120
NADA 141-251 original approval
Sponsor: Bayer HealthCare LLC
Generic Name: imidacloprid + 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 141-253 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 141-255 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:
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 141-259 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 141-264 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 141-267 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 141-278 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 141-280 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 141-285 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 141-289 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 141-302 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
ANADA 200-007 original approval
Sponsor: Happy Jack® Inc.
Generic Name: pyrantel pamoate
Trade Name: Liqui-Vict 2X™
Indications for Use: To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
For removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies.
Date of Approval: October 30, 1996
ANADA 200-008 original approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200, BIO-MYCIN® 200
Indications for Use: OXY-TET 200/BIO-MYCIN 200 is intended for use in the treatment of the following diseases in beef cattle, nonlactating dairy cattle and swine when due to oxytetracycline susceptible organisms. CATTLE: OXY-TET 200 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis ; foot rot and diphtheria caused by Fusobacterium necrophorum ; bacterial enteritis (scours) caused by Escherichia coli ; wooden tongue caused by Actinobacillus lignieresi ; leptospirosis caused by Leptospira pomona ; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. SWINE: In swine, OXY-TET 200 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli ; pneumonia caused by Pasteurella multocida ; and leptospirosis caused by Leptospira pomona . In sows, OXY-TET 200 is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
Date of Approval: November 16, 1994
ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200; BIO-MYCIN® 200
Effect of Supplement: To add the subcutaneous route of administration to the label for cattle.
Date of Approval: May 22, 1996
ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200; BIO-MYCIN® 200
Effect of Supplement: This supplemental application establishes a 28 day withdrawal period for subcutaneous use in cattle and intramuscular use in swine (all approved routes of administration in cattle and swine).
Date of Approval: March 16, 1999
ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Oxytetracycline injection
Trade Name: BIO-MYCIN® 200
Effect of Supplement: This supplemental application provides for the use in lactating cattle.
Date of Approval: September 3, 2002
ANADA 200-023 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: gentamicin sulfate solution
Trade Name: Gentamicin Sulfate Solution 100 mg/mL
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: August 4, 1995
ANADA 200-026 original approval
Sponsor: PennField Oil Company
Generic Name: oxytetracylcline hydrochloride
Trade Name: Pennox 343
Indications for Use: Control of certain diseases caused by bacteria susceptible to oxytetracycline hydrochloride.
Date of Approval: March 13, 1997
ANADA 200-026 supplemental approval
Sponsor: PennField Oil Company
Generic Name: oxytetracylcline hydrochloride
Trade Name: Pennox 343
Effect of Supplement: Revised withdrawal period (0-day) in turkeys & additional package size of 23.9 oz..
Date of Approval: February 5, 1999
ANADA 200-026 supplemental approval
Sponsor: PennField Oil Company
Generic Name: Oxytetracycline hydrochloride
Trade Name: Pennox™ 343
Effect of Supplement: Revised withdrawal period (0-day) in swine
Date of Approval: April 10, 2002
ANADA 200-027 supplemental approval
Sponsor: Planalquimica Industrial Ltd
Generic Name: nicarbazin
Trade Name: Nicarmix (nicarbazin) 25%
Effect of Supplement: This supplement approves Nicarmix (nicarbazin) 25%, as manufactured by Planalquimica, as an equivalent to nicarbazin sold by Merck.
Date of Approval: May 30, 1995
ANADA 200-028 original approval
Sponsor: LAMBERT KAY
Generic Name: Pyrantel pamoate
Trade Name: Evict®, Lassie®, Vet's Own™
Indications for Use: Evict® should be used to prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping and for removal of large roundworms and hookworms in dogs and puppies.
Date of Approval: March 28, 1996
ANADA 200-028 supplemental approval
Sponsor: Lambert-Kay
Generic Name: pyrantel pamoate
Trade Name: Evict® DS and Lassie® DS Liquid Wormer plus Vet's Own™ DS Canine Anthelmintic Suspension
Effect of Supplement: Provides for a double strength pyrantel pamoate suspension.
Date of Approval: June 4, 1997
ANADA 200-029 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: ketamine hydrochloride injection
Trade Name: Ketamine Hydrochloride Injection
Indications for Use: Ketamine Hydrochloride Injection may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: August 16, 1995
ANADA 200-030 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: sulfadimethoxine 12.5% oral solution
Trade Name: Sulfadimethoxine 12.5% Oral Solution
Indications for Use: BROILER AND REPLACEMENT CHICKENS: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. MEAT PRODUCING TURKEYS: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. FOR DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: December 31, 1992
ANADA 200-031 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: sulfadimethoxine
Trade Name: Sulfadimethoxine Antibacterial Soluble Powder
Indications for Use: BROILER AND REPLACEMENT CHICKENS: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. MEAT PRODUCING TURKEYS: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. DAIRY CALVES, DAIRY HEIFERS AND BEEF: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: June 17, 1992
ANADA 200-033 original approval
Sponsor: Macleod Pharmaceuticals, Inc.
Generic Name: trimethoprim/sulfadiazine
Trade Name: Uniprim Powder
Indications for Use: For control of bacterial infections of horses during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections and abscesses.
Date of Approval: June 11, 1993
ANADA 200-037 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: gentamicin 100 mg/mL solution
Trade Name: Gentamicin Sulfate Solution
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: February 8, 1993
ANADA 200-038 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: sulfadimethoxine
Trade Name: Sulfadimethoxine Injection 40%
Indications for Use: Recommended in cattle for the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum , sensitive to sulfadimethoxine.
Date of Approval: May 25, 1993
ANADA 200-042 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name: ketamine hydrochloride injection, USP
Trade Name: Ketaject®
Indications for Use: Ketaject® (ketamine hydrochloride injection. USP) may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: June 30, 1994
ANADA 200-046 original approval
Sponsor: Pfizer Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Soluble Powder 325 gm/lb
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep, and goats.
Date of Approval: May 15, 1992
ANADA 200-046 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Sulfate Soluble Powder 325 g/lb
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats.
Date of Approval: April 03, 1996
ANADA 200-049 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: tetracycline hydrochloride
Trade Name: TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER-324
Indications for Use: For use in the control and treatment of the following conditions in swine, calves and poultry. SWINE: Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline. Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline. CHICKENS: Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli ; infectious synovitis caused by Mycoplasma synoviae susceptible to tetracycline. TURKEYS: Control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, corona viral enteritis) caused by complicating bacterial organisms susceptible to tetracycline.
Date of Approval: September 30, 1993
ANADA 200-050 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: February 15, 1995
ANADA 200-050 supplemental approval
Sponsor: Rhone-Merieux, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats.
Date of Approval: April 03, 1996
ANADA 200-050 supplemental approval
Sponsor: Bimeda, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Effect of Supplement: This supplement provides for use of the addition of a new species, turkeys..
Date of Approval: July 10 2002
ANADA 200-055 original approval
Sponsor: Lloyd Incorporated
Generic Name: ketamine hydrochloride solution, USP
Trade Name: VetaKet ™
Indications for Use: VetaKetTM may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: August 3, 1998
ANADA 200-061 original approval
Sponsor: AgriLabs
Generic Name: flunixin meglumine
Trade Name: (to be established)
Indications for Use: "Tradename" (flunixin meglumine) Solution is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
Date of Approval: September 11, 1996
ANADA 200-061 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: flunixin meglumine
Trade Name: Flunixin Meglumine Solution
Effect of Supplement: This supplement provides for the addition of a claim for intravenous use in beef cattle and nonlactating dairy cattle to the labeling of the approved product Flunixin Meglumine Solution. The exclusivity period protecting this claim for the pioneer product expired on May 6, 2001.
Date of Approval: July 29, 2004
ANADA 200-066 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: oxytetracycline hydrochloride
Trade Name: Agrimyn™-343 Soluble Powder
Indications for Use: CHICKENS - INDICATIONS: Control of infectious synovitis caused by Mycoplasma synoviae . Dosage: 200-400 mg/gal. Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli . Dosage: 400-800-mg/gal. Control of fowl cholera caused by Pasteurella multocida . Dosage: 400-800-mg/gal. TURKEYS- INDICATIONS: Control of Hexamitiasis caused by Hexamita meleagridis . Dosage: 200-400 mg/gal. Control of infectious synovitis caused by Mycoplasma synoviae . Dosage: 400 mg/gal. Growing turkeys: Control of body weight complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) Dosage: 25 mg/lb. SWINE - INDICATIONS: FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE: Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis , susceptible to oxytetracycline. Bacterial pneumonia caused by Pasteurella multocida , susceptible to oxytetracycline. Dosage: 10 mg/lb body weight. FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona , susceptible to oxytetracycline. Dosage: 10 mg/lb body weight. GENERAL DIRECTIONS: Mix fresh solutions daily. Use as sole source of drinking water. Do not mix this product directly with milk or milk replacers. Administer one hour before or two hours after feeding milk or milk replacers. Consult a poultry diagnostic laboratory or poultry pathologist for diagnosis or advice on dosage for chickens or turkeys. As a generalization, 200 chickens will drink one gallon of water per day for each week of age. Turkeys will consume twice that amount. Administer up to 5 days to swine and 7 to 14 days for chickens and turkeys.
Date of Approval: July 15, 1994
ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline HCl
Trade Name: AGRIMYCIN® 343 SOLUBLE POWDER
Effect of Supplement: Revised withdrawal period for turkeys and swine.Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).Based upon the formulation characteristics of the genetic product, Agri Laboratories Ltd. was granted a waiver from conducting an in vivo bioequivalence study for Oxytetracycline HCl Soluble Powder. The genetic and pioneer products contain the same active ingredient and are water soluble powders administered as oral solutions. The genetic product contains no inactive ingredients that may significantly affect the absorption of the active ingredient.
Date of Approval: October 04, 2001
ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Agrimycin® 166
Effect of Supplement: The supplement provides for approval of an additional packet size, 9.87 oz [280 g], a different trade name, an alternate concentration of active ingredient and a change in the inactive ingredients in the finished dosage form.
Date of Approval: June 30, 2004
ANADA 200-068 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTETRACYCLINE Hydrochloride Injection
Indications for Use: OXYTETRACYCLINE HCLINJECTABLE SOLUTION is for treatment of: Pasteurella spp. -- Bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; Escherichia coli -- Bacterial enteritis (scours); Spherophorous necrophorus -- Necrotic pododermatitis (foot rot), calf diphtheria; Actinobacillus lignierseii -- Wooden tongue; wound infection,acute metritis, and traumatic injury -- caused by oxytetracycline susceptible strains of streptococcal and staphylococcal bacteria.
Date of Approval: July 31, 1995
ANADA 200-069 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: gonadorelin diacetate tetrahydrate injection
Trade Name: Fertelin™ (Gonadorelin Diacetate Tetrahydrate) Sterile Solution
Indications for Use: Fertelin (Gonadorelin) is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus.Historically, cyctic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotropin. Fertelin initiates release of endogenous LH to cause ovulation and luteinization
Date of Approval: August 01, 2002
ANADA 200-070 original approval
Sponsor: Abbott Laboratories
Generic Name: isoflurane, USP
Trade Name: IsoFlo™
Indications for Use: IsoFlo (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.
Date of Approval: March 11, 1993
ANADA 200-071 original approval
Sponsor: Delmarva Laboratories, Incorporated
Generic Name: pentobarbital sodium and phenytoin sodium
Trade Name: Euthasol™
Indications for Use: For use in dogs for humane, painless, and rapid euthanasia
Date of Approval: February 24, 1994
ANADA 200-073 original approval
Sponsor: American Veterinary Products, Inc.
Generic Name: ketamine hydrochloride injection, USP
Trade Name: ketamine hydrochloride injection, USP
Indications for Use: Ketamine hydrochloride injection, USP may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: July 21, 1994
ANADA 200-075 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium
Trade Name: Sacox®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati
Date of Approval: February 23, 1994
ANADA 200-075 supplemental approval
Sponsor: Intervet Inc.
Generic Name: salinomycin sodium
Trade Name: Sacox®
Indications for Use: To add roaster and replacement (breeder and layer) chickens to the label claim for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and to add quail to the label claim for the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae.
Date of Approval: November 8, 2002
ANADA 200-080 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: Salinomycin sodium, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Bambermycins
Trade Name: Sacox, 3-Nitro, Roxarsone, Flavomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: March 8, 1994
ANADA 200-081 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin methylene disalicylate
Trade Name: Sacox, 3-Nitro, BMD
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for increased rate of weight gain.
Date of Approval: March 4, 1994
ANADA 200-082 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bacitracin methylene disalicylate
Trade Name: Sacox, BMD
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for rate of weight gain and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(iii)]. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(vi)]
Date of Approval: March 18, 1994
ANADA 200-083 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bambermycins
Trade Name: Sacox, Flavomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , and for improved feed efficiency.
Date of Approval: March 18, 1994
ANADA 200-086 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin zinc
Trade Name: Sacox, 3-Nitro, Albac
Indications for Use: For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for improved feed efficiency in broiler chickens; and for increased rate of weight gain and improved feed efficiency.
Date of Approval: March 28, 1994
ANADA 200-088 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: xylazine hydrochloride
Trade Name: Sedazine™
Indications for Use: Sedazine (xylazine) should be used in horses and Cervidaewhen it is desirable to produce a state of sedation accompanied by a shorter period of analgesia. HORSES: Sedazine has been used successfully as follows: Diagnostic procedures -- oral and opthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations. Orthopedic procedures, such as application of casting materials and splints. Dental procedures. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations. To calm and facilitate handling of fractious animals. Therapeutic medication for sedation and relief of pain following injury or surgery. Major surgical procedures: when used as a preanesthetic to general anesthesia; when used in conjunction with local anesthetics. CERVIDAE : Sedazine may be used for the following: To calm and facilitate the handling of fractious animals. Diagnostic procedures. Minor surgical procedures. Therapeutic medication for sedation and relief of pain following injury or surgery. As a preanesthetic to local anesthesia. Sedazine at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.
Date of Approval: February 24, 1994
ANADA 200-089 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bacitracin zinc
Trade Name: Sacox, Baciferm
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain.
Date of Approval: April 6, 1994
ANADA 200-090 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), lincomycin
Trade Name: Sacox, 3-Nitro, Lincomix
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-091 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex/roxarsone
Trade Name: Sacox and 3-Nitro and Aureomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994
ANADA 200-092 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, virginiamycin
Trade Name: Sacox, Stafac
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(x)]. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain. [21 CFR § 558.550 (b)(1)(xi)]
Date of Approval: April 6, 1994
ANADA 200-093 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, lincomycin
Trade Name: Sacox Lincomix
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-094 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone, virginiamycin
Trade Name: Sacox 3-Nitro Stafac
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-095 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex
Trade Name: Sacox and Aureomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti ,and E. mivati , and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994
ANADA 200-096 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/oxytetracycline
Trade Name: Sacox and Terramycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti , and E. mivati , and as an aid in the reduction of mortality due to airsacculitis (air sac infection) caused by Escherichia coli infections sensitive to oxytetracycline.
Date of Approval: November 25, 1994
ANADA 200-097 original approval
Sponsor: Hoechst-Roussel Agri Vet Company
Generic Name: salinomycin sodium, roxarsone
Trade Name: Sacox 3-Nitro
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-102 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: gentamicin sulfate solution
Trade Name: Gentaglyde™ Solution
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: May 19, 1994
ANADA 200-103 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: penicillin G potassium, USP
Trade Name: Penicillin G Potassium, USP
Indications for Use: For the treatment of erysipelas in turkeys caused by Erysipelothrix rhusiopathiae .
Date of Approval: October 18, 1994
ANADA 200-106 original approval
Sponsor: I.D. Russell Company
Generic Name: penicillin G potassium
Trade Name: R-Pen
Indications for Use: For treatment of erysipelas in turkeys (caused by Erysipelothrix rhusiopathiae).
Date of Approval: July 21, 1994
ANADA 200-108 original approval
Sponsor: Phoenix Pharmaceuticals, Inc.
Generic Name: Dexamethasone Solution
Trade Name: Dexamethasone Solution
Indications for Use: Treatment of primary bovine ketosis and as an anti-inflammatory agent in dogs, cats, cattle, and horses.
Date of Approval: April 13, 1995
ANADA 200-109 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: vitamin E/selenium injection
Trade Name: Velenium™ (SELENIUM, VITAMIN E)
Indications for Use: Velenium™ (SELENIUM, VITAMIN E) is recommended for the prevention and treatment of Selenium-Tocopherol Deficiency syndrome in weanling calves and breeding beef cattle.
Date of Approval: October 20, 1995
ANADA 200-113 original approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name: Biosol® Liquid
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: June 28, 1993
ANADA 200-113 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: neomycin sulfate
Trade Name: Biosol® Liquid
Effect of Supplement: Changes withdrawal times and tolerance information.
Date of Approval: February 7, 1997
ANADA 200-115 original approval
Sponsor: Macleod Pharmaceuticals, Inc.
Generic Name: gentamicin sulfate solution
Trade Name: Gentamex™ 100
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: July 21, 1995
ANADA 200-117 original approval
Sponsor: Cross Vetpharm Group Limited
Generic Name: oxytetracycline injection
Trade Name: Oxyshot™ LA
Indications for Use: For the treatment of diseases caused by bacteria susceptible to oxytetracycline.
Date of Approval: April 13, 1995
ANADA 200-118 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Oral Solution
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: November 29, 1994
ANADA 200-118 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Neomycin Sulfate
Trade Name: Neomycin Oral Solution
Effect of Supplement: To revise the withdrawal period to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats to be identical to pioneer product.
Date of Approval: July 14, 1998