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U.S. Department of Health and Human Services

Animal & Veterinary

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200-241 to 200-350

ANADA 200-241 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Lincomycin Hydrochloride Soluble Powder
Trade Name: Lincosol Soluble Powder
Indications for Use: Swine: For the treatment of swine dysentery (bloody scours).
Broiler chickens: For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.
Tolerance: 21CFR 556.360: 0.6 ppm for parent lincomycin (marker residue) in the liver (target tissue) of swine and 0.1 ppm for parent lincomycin in muscle. The Acceptable Daily Intake (ADI) is established at 0.025 mg/kg of body weight/day.
Date of Approval: February 4, 1999

ANADA 200-242 original approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: Chlortetracycline, Bacitracin Methylene Disalicylate
Trade Name: BMD®-25, BMD®-30, BMD®-40, BMD®-50, BMD®-60 or BMD®-75; and Aureomycin® -50, -70, -80, -90 or -100.
Indications for Use: For increased rate of weight gain and improved feed efficiency
Date of Approval: January 16, 1998

ANADA 200-244 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: trimethoprim/sulfadiazine powder
Trade Name: Tucoprim® 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: October 22, 1999

ANADA 200-245 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide cream.
Trade Name: Derma-Vet Cream
Indications for Use: Derma-Vet Cream is indicated in the management of dermatologic disorders in dogs and cats, characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated or threatened by bacterial or candidal (Candida albicans) infections. It is also of value in eczematous dermatitis, contact dermatitis and seborrheic dermatitis; and as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: June 7, 1999

ANADA 200-246 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate usp
Trade Name: Anthelban V
Indications for Use: For the removal and control of matureinfections of large strongyles (Strongylus vulgaris, S.edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascarisequorum); and small strongyles in horses and ponies.
Date of Approval: June 18, 1998

ANADA 200-246 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate
Trade Name: Pyrantel Pamoate Equine Anthelmintic Suspension
Indications for Use: For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum); and small strongyles in horses and ponies.
Date of Approval: August 19, 2003

ANADA 200-247 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Oxytetracycline HCL Soluble Powder-343
Indications for Use: Chickens: For the control and treatment of infectious synovitis caused by Mycoplasma synoviae; chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida.
Turkeys: For the control and treatment of hexamitiasis caused by Hexamita meleagridis; infectious synovitis caused by Mycoplasma synoviae; and control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).
Cattle: For the treatment and control in calves, beef cattle and nonlactating dairy cattle of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
Swine: For the control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, bacterial pneumonia caused by Pasteurella multocida; and reducing the incidence of abortions and shedding of leptospira in breeding swine caused by Leptospira pomona.
Sheep: For the treatment and control of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
Date of Approval: February 10, 1999

ANADA 200-247 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Oxytetracycline HCl
Trade Name: OXYTETRACYCLINE HCL SOLUBLE POWDER-343
Indications for Use: OXYTETRACYCLINE HCL SOLUBLE POWDER – 343 is indicated for a variety of bacterial infections in cattle, sheep, swine, chickens, turkeys, and honeybees associated with organisms susceptible to oxytetracycline.
CALVES, BEEF CATTLE AND NON-LACTATING DAIRY CATTLE: Control and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
SHEEP: Control and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
SWINE: Control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida. For Breeding Swine: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona.
CHICKENS: Control of infectious synovitis caused by Mycoplasma synoviae, chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli, and fowl cholera caused by Pasteurella multocida.
TURKEYS: Control of hexamitiasis caused by Hexamita meleagridis and infectious synovitis caused by Mycoplasma synoviae. Growing turkeys-complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).
HONEYBEES: Control and treatment of American and European foulbrood caused by Bacillus larvae.
Date of Approval: November 12, 2003

ANADA 200-247 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Oxytetracycline HCl
Trade Name: OXYTETRACYCLINE HCL SOLUBLE POWDER-343
Effect of Supplement: This supplemental applicaiton provides for the additional use in a new species, finfish fry and fingerlings, for skeletal marking by immersion as an aid in identification.
Date of Approval: September 15, 2004

ANADA 200-248 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel Pamoate USP
Trade Name: Pyrantel Pamoate Suspension - 4.54mg, Pyrantel Pamoate Suspension - 2.27mg
Indications for Use: To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping. For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. The presence of these parasites should be confirmed by laboratory fecal examination.
Date of Approval: July 16, 1998

ANADA 200-251 original approval
Sponsor: Med Pharmex, Inc.
Generic Name: Sulfadimethoxine
Trade Name: Sulforal®
Indications for Use: Broiler and Replacement Chickens: For the treatment of coccidiosis, fowl cholera and infectious coryza-concentration: 0.05% 1 fl. oz to 2 gallons of drinking water. Meat-Producing Turkeys:For the treatment of coccidiosis and fowl cholera-concentration: 0.025% 1 fl. oz to 4 gallons of drinking water. Dairy Calves, Dairy Heifers and Beef Cattle: For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot-dosage: 25 mg/lb first day followed by 12.5 mg/lb for 4 days (as drinking water or drench)
Date of Approval: August 3, 1998

ANADA 200-253 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Dinoprost tromethamine
Trade Name: ProsaMate™ Sterile Solution
Indications for Use: For estrus synchronization, treatment of unobserved (silent) estrus and pyometra (chronic endometritis) in cattle; for abortion of feedlot and other non-lactating cattle; for parturition in swine; and for controlling the timing of estrus in estrous cycling mares and clinically anestrous mares that have a corpus luteum.
Date of Approval: February 12, 1999

ANADA 200-254 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: iron Hydrogenated Dextran
Trade Name: iron Dextran Injection (100 mg/mL)
Indications for Use: For the prevention or treatment of iron deficiency anemia in baby pigs
Date of Approval: July 14, 1998

ANADA 200-256 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: iron Dextran Complex
Trade Name: iron Dextran Injection-200
Indications for Use: For the prevention or treatment of anemia due to iron deficiency
Date of Approval: August 17, 1998

ANADA 200-257 original approval
Sponsor: Vetrepharm Research, Inc.
Generic Name: Ketamine hydrochloride injection USP
Trade Name: Ketamine HCl
Indications for Use: 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. Used in subhuman primates for restraint.
Date of Approval: November 09, 2001

ANADA 200-258 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Sulfadimethoxine Soluble Powder
Trade Name: Sulfadimethoxine Soluble Powder
Indications for Use: Chickens: For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. Turkeys: For the treatment of disease outbreaks of coccidiosis and fowl cholera. Cattle: For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Date of Approval: March 4, 1999

ANADA 200-259 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium, roxarsone
Trade Name: ChlorMax™, 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, 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 treatments.
Date of Approval: September 21, 1998

ANADA 200-260 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium, roxarsone
Trade Name: ChlorMax™, Bio-Cox®, 3-Nitro®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, 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 treatments.
Date of Approval: September 21, 1998

ANADA 200-261 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium
Trade Name: ChlorMax™/ Bio-Cox®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatments.
Date of Approval: September 21, 1998

ANADA 200-262 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium
Trade Name: ChlorMax™/Sacox®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatments.
Date of Approval: September 21, 1998

ANADA 200-263 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, monesin sodium
Trade Name: ChlorMax™/Coban®
Indications for Use: As an aid in the reduction of mortality due to E. coli infections susceptible to such treatmentsand in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
Date of Approval: September 21, 1998

ANADA 200-265 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Praziquantel
Trade Name: Praziquantel Tablets
Indications for Use: For the removal of Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus and for the removal and control of Echinococcus multilocularis.
Date of Approval: August 28, 2003

ANADA 200-265 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Praziquantel
Trade Name: Prazi-C Tablets
Effect of Supplement: This supplement provides for OTC marketing of Prazi-C (praziquantel) Tablets in 5, 10, and 50-tablet container sizes.
Date of Approval: September 15, 2004

ANADA 200-266 original approval
Sponsor: Bioniche Animal Health, Inc.
Generic Name: Phenylbutazone Paste
Trade Name: Butequine ®
Indications for Use: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: February 21, 2003

ANADA 200-270 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Ivermectin Tablets
Trade Name: Iverhart
Indications for Use: Iverhart is indicated for the prevention of canine heartworm (Dirofilaria immitis) disease
Date of Approval: November 30, 2001

ANADA 200-271 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Levamisole Phosphate
Trade Name: Levamisole phosphate
Indications for Use: For treatment in cattle excluding dairy animals of breeding age with the following nematode infections: STOMACH WORMS: (Haemonchus, Ostertagia, Trichostrongylus) INTESTINAL WORMS: (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia)
Date of Approval: September 7, 2000

ANADA 200-272 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: Noromectin® Pour-On for Cattle
Indications for Use: NOROMECTIN (ivermectin) Pour-On for Cattle when applied at the recommended dose of 500 mcg/kg is indicated for the effective control and treatment of gastrointestinal roundworms (including Ostertagia ostertagi) lungworms, grubs, hornflies, sucking and biting lice, and sarcoptic mange mites in cattle.
Date of Approval: September 13, 2004

ANADA 200-272 supplemental approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: NOROMECTIN
Effect of Supplement: The effect of the supplement is to add claims that are no longer protected by three years marketing exclusivity that expired on November 24, 2006, specifically: Dictyocaulus viviparus for 28 days, Cooperia surnabada for 14 days, and Damalinia bovis for 56 days after treatment. Also, the persistent activity periods are extended for the following: Oesophagostomum radiatum from 14 days to 28 days and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment.
Date of Approval: January 19, 2007

ANADA 200-273
Sponsor: Altana, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Vetro-Gen™ Veterinary Ophthalmic Ointment
Indications for Use: For treatment of conjunctivitis caused by susceptible bacteria.
Date of Approval: June 8, 2004

ANADA 200-274 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lincomycin HCL
Trade Name: Lincomycin Injectable 30%
Indications for Use: For the treatment of infectious arthritis and mycoplasmal pneumonia.
Date of Approval: February 1, 2002

ANADA 200-275 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Triamcinolone Acetonide Cream
Trade Name: Medalone Cream
Indications for Use: Medalone Cream (Triamcinolone Acetonide Cream) is indicated for topical treatment of allergic dermatitis and summer eczema in dogs.
Date of Approval: February 4, 2000

ANADA 200-279 original approval
Sponsor: Abbott Laboratories
Generic Name: Ketamine Hydrochloride Injection
Trade Name: KetaFlo™
Indications for Use: 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 13, 2000

ANADA 200-280 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Pentobarbital sodium and phenytoin sodium
Trade Name: Euthanasia-III Solution
Indications for Use: For use in dogs for humane, painless, and rapid euthanasia.
Date of Approval: February 3, 2005

ANADA 200-281 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Flavored Pyrantel Pamoate Tablets
Trade Name: To be determined
Indications for Use: For the removal of large roundworms (ascarids) (Toxocara canis; Toxascaris leonina) and hookworms (Ancylostoma caninum; Uncinaria stenocephala) in dogs and puppies. To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
Date of Approval: January 3, 2001

ANADA 200-282 original approval
Sponsor: Farnam Companies, Inc
Generic Name: Pyrantel tartrate
Trade Name: Continuex™
Indications for Use: For the prevention of Strongylus vulgaris larval infestation in horses and for control of the following parasites. Large strongyles (adults): S. vulgaris, S. edentatus; Small strongyles (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., Triodontophorus spp.; Pinworms (adults and fourth-stage larvae): Oxyuris equi; Ascarids (adults and fourth-stage larvae): Parascaris equorum
Date of Approval: September 26, 2000

ANADA 200-283 original approval
Sponsor: Altana Inc.
Generic Name: Gentamicin sulfate, USP, betamethasone valerate, USP, and clotrimazole, USP
Trade Name: VETRO-MAX
Indications for Use: For the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
Date of Approval: June 1, 2006

ANADA 200-286 supplemental approval

Sponsor: IVX Animal Health, Inc.
Generic Name: Ivermectin
Trade Name: Phoenectin® Paste 1.87%
Indications for Use: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.  PHOENECTIN (ivermectin) Paste 1.87% provides effective treatment and control of the following parasites in horses.  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: December 18, 2008

ANADA 200-286 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin Paste 1.87%
Trade Name: PhoenectinTM (ivermectin) Paste 1.87%
Indications for Use: For treatment and control of the parasites or parasitic conditions. Large strongyles (adults): S. vulgaris (and arterial larval stages), S. edentatus (and tissue stages), S. equinus, Triodontophorus spp.; Small strongyles (adults and fourth-stage larvae) including those resistant to some benzimidizole class compounds: Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.; 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): Gastrophilus spp.; 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 spp.
Date of Approval: September 20, 2000

ANADA 200-287 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Gentamicin Sulfate, Betamethasone Valerate and Clotrimazole Ointment
Trade Name: GBC Ointment™
Indications for Use: Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin
Date of Approval: March 28, 2003

ANADA 200-287 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP
Trade Name: TRIPLEMAX (gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP Ointment)
Effect of Supplement: This supplement provides for an additional package size, 20-gram fill in a 30 mL bottle. The bottle will be the same LDPE as the approved 15 mL bottle, and the plug, dropper and cap will be the exact same closure as the approved package.
Date of Approval: January 21, 2005

ANADA 200-287 supplemental approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Gentamicin sulfate, betamethasone valerate, clotrimazole
Trade Name: TripleMax™
Effect of Supplement: This application provides for a new container size (40 gram dropper bottle).
Date of Approval: August 23, 2006

ANADA 200-289 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: neomycin sulfate
Trade Name: Neoral 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: July 3, 2000

ANADA 200-291 original approval
Sponsor: Delmarva Laboratories, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clinsol®
Indications for Use: For the treatment of infections caused by susceptible strains of the designated microorganism in the specific conditions listed for Dogs and Cats.
Date of Approval: August 26, 2002

ANADA 200-292 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin
Trade Name: Iversol Liquid for Horses
Indications for Use: For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, large-mouth stomach worms, bots, lungworms, summer sores and cutaneous onchocerciasis.
Date of Approval: December 7, 2000

ANADA 200-293 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Furosemide Injection 5 %
Trade Name: Furosemide Injection 5 %
Indications for Use: Diuretic-saluretic for prompt relief of edema.
Date of Approval: December 18, 2001

ANADA 200-295 original approval
Sponsor: PennField Oil Company
Generic Name: chlortetracycline HCL powder
Trade Name: Pennchlor™ 64
Indications for Use: Calves (not veal), beef cattle and nonlactating dairy cattle and swine:
Control of bacterial pneumonia (Pasteurella spp., Hemophilus spp., Klebsiella spp.) and bacterial enteritis (Escherichia coli, Salmonella spp.).Turkeys:Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis or Coronavirus enteritis) susceptible to chlortetracycline. Also for the control of infectious synovitis (Mycoplasma synoviae).Chickens:Control of chronic respiratory disease (CRD) and air-sac infection (Mycoplasma gallisepticum, Escherichia coli). Also for the control of mortality due to fowl cholera (Pasteurella multocia) in growing chickens.
Date of Approval: April 27, 2001

ANADA 200-298 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin Hydrochloride Capsules
Trade Name: Clindamycin Hydrochloride Capsules
Indications for Use: For the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed in the approval.
Date of Approval: June 14, 2002

ANADA 200-298 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clindamycin Hydrochloride Capsules
Effect of Supplement: For the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
Date of Approval: April 21, 2004

ANADA 200-299 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Ivermectin Pour-On for Cattle
Indications for Use: For the effective control and treatment of these parasites in cattle: Gastrointestinal Roundworms; Lungworms; Cattle Grubs; Mites; Lice; Horn Flies It is also used to control infections of gastrointestinal roundworms: O. ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
Date of Approval: December 28, 2000

ANADA 200-299 supplemental approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin
Trade Name: IVER-ON
Effect of Supplement: The effect of the supplement is the addition of CVM requested changes to the Environmental Safety, Disposal statement, and Residue Information portions of the labeling and the addition of claims that are no longer protected by three years marketing exclusivity that expired on November 24, 2006, specifically: Dictyocaulus viviparus for 28 days, Cooperia surnabada for 14 days, and Damalinia bovis for 56 days after treatment. Also, the persistent activity periods are extended for the following: Oesophagostomum radiatum from 14 days to 28 days and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment.
Date of Approval: May 7, 2007

ANADA 200-301 original approval
Sponsor: First Priority, Inc.
Generic Name: Chlorhexidine Antiseptic Ointment
Trade Name: Privasan™ Antiseptic Ointment
Indications for Use: Privasan™ Antiseptic Ointment is used as a topical antiseptic ointment for surface wounds on dogs, cats, and horses.
Date of Approval: November 6, 2001

ANADA 200-302 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Ivermectin and Pyrantel (as pamoate salt)
Trade Name: Iverhart™ Plus Flavored Chewables
Indications for Use: For the prevention of canine heartworm (Dirofilaria immitis) disease and for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala, and Ancylostoma braziliense in dogs over 6 weeks of age.
Date of Approval: May 30, 2001

ANADA 200-303 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Lincomycin Hydrochloride Soluble Powder
Trade Name: Lincomycin Hydrochloride Soluble Powder
Indications for Use: For treatment of swine and broiler chickens
Date of Approval: October 1, 2002

ANADA 200-304 original approval
Sponsor: First Priority, Inc.
Generic Name: Copper naphthenate solution
Trade Name: Pritox™
Indications for Use: FAs an aid in treating horses and ponies with thrush due to organisms susceptible to copper naphthenate.
Date of Approval: July 25, 2003

ANADA 200-305 original approval
Sponsor: Vétoquinol N.-A., Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Oxytetracycline hydrochloride soluble powder
Indications for Use: For the treatment of bacterial diseases in chickens, turkeys, and swine.
Date of Approval: June 2, 2006

ANADA 200-306 original approval
Sponsor: Norbrook Laboratories, Inc.
Generic Name: Oxytetracycline injection
Trade Name: Oxytetracycline Injection 200 mg/mL
Indications for Use: Cattle: For the treatment of pneumonia and shipping fever complex...
Swine: For the treatment of the bacterial enteritis...
Date of Approval: June 18, 2002

ANADA 200-307 original approval
Sponsor: Vétoquinol N.-A., Inc.
Generic Name: Penicillin G potassium
Trade Name: Penicillin G Potassium, USP
Indications for Use: For the treatment of erysipelas caused by Erysipelothrix rhusiopathiae.
Date of Approval: January 29, 2004

ANADA 200-308 original approval
Sponsor: Norbrook Laboratories Ltd
Generic Name: Flunixin meglumine
Trade Name: Flunixin Injection (50 mg/mL)
Indications for Use: It is indicated for the alleviation of inflammation and pain associated with musculoskeletal disorders in the ANADA 200-308 horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. In cattle, it is indicated for the control of pyrexia associated with bovine respiratory disease and endotoxemia. Flunixin Injection is also indicated for control of inflammation in endotoxemia.
Date of Approval: November 17, 2003

ANADA 200-308 supplemental approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Flunixin meglumine
Trade Name: Flunixin Injectable
Effect of Supplement: This supplement provides for the addition of use in lactating dairy cattle for the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia.
Date of Approval: March 1, 2006

ANADA 200-312 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Dexamethasone
Trade Name: DEXIUM
Indications for Use: For treatment of primary bovine ketosis and as an anti-inflammatory agent in the canine, feline, bovine and equine.
Date of Approval: October 20, 2003

ANADA 200-313 original approval
Sponsor: Phoenix Scientific, Inc
Generic Name: Levamisole hydrochloride
Trade Name: Levamisole Hydrochloride Soluble Pig Wormer
Indications for Use: For the treatment effective against nematode infections.
Date of Approval: October 25, 2002

ANADA 200-314 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline calcium complex and sulfamethazine
Trade Name: PENNCHLOR S 700™
Indications for Use: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever.
Date of Approval: January 29, 2003

ANADA 200-315 original approval
Sponsor: Veterinary Laboratories, Inc.
Generic Name: Lincomycin hydrochloride monohydrate
Trade Name: Lincomycin 25, Lincomycin 100, Lincomycin 300
Indications for Use: For the treatment of infectious arthritis and mycoplasma pneumonia.
Date of Approval: April 2, 2003

ANADA 200-316 original approval
Sponsor: Delmarva Laboratories, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clintabs®
Indications for Use: For treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed in the approval
Date of Approval: June 6, 2002

ANADA 200-317 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Dexamethasone sodium phosphate
Trade Name: Dexium-SP™
Indications for Use: For use as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.
Date of Approval: April 29, 2004

ANADA 200-318 original approval
Sponsor: Virbac AH, Inc..
Generic Name: Ivermectin Topical Liquid
Trade Name: Virbamec™ Pour-On for Cattle
Indications for Use: For the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, horn flies, sucking and biting lice, chorioptic and sarcoptic mange mites. Treatment for horn flies for 28 days. It is also use to control infections of gastrointestinal roundworms: O. ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
Date of Approval: September 21, 2001

ANADA 200-318 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin
Trade Name: VIRBAMEC Pour-on for Cattle
Effect of Supplement: The effect of the supplement is the addition of a new 10 L package size; and revised labeling that includes updated (a) speciation of Cooperia, (b) Environmental Safety information, (c) Mode of Action information, (d) Residue Information, and (e) Indications section.
Date of Approval: July 6, 2007

ANADA 200-318 supplemental approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Ivermectin
Trade Name: Bimectin® Pour-On
Effect of Supplement: This supplemental ANADA provides for approval of the proprietary name Bimectin® Pour-On and updates to the persistent activity statement to be consistent with the reference listed new animal drug as follows: Bimectin® (ivermectin) Pour-On has been proved to effectively control infections and to protect cattle from re-infection with:  Oesophagostomum radiatum and Dictyocaulus viviparous for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.
Date of Approval: September 21, 2011

ANADA 200-319 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Acepromazine Maleate Injection
Trade Name: Acepromazine Maleate Injection
Indications for Use: Dogs and Cats: Acepromazine Maleate Injection can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. Acepromazine Maleate Injection is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia; (2) as an adjunct to surgery under local anesthesia. Horses: Acepromazine Maleate Injection can be used as an aid in controlling fractious animals during examination, treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts.
Date of Approval: March 25, 2003

ANADA 200-320 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin Paste
Trade Name: Equell™ (ivermectin) Paste
Indications for Use: For the treatment and control of parasitic conditions.
Date of Approval: August 9, 2002

ANADA 200-320 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin
Trade Name: EQUELL
Effect of Supplement: The effect of the supplement is to incorporate CVM requested changes to the label’s “WARNING” and “INDICATIONS” sections and to add expired three-year exclusivity claims
Date of Approval: October 24, 2006

ANADA 200-321 original approval
Sponsor: First Priority, Inc
Generic Name: Ivermectin Liquid for Horses
Trade Name: Primectin™ Equine Oral Liquid
Indications for Use: For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, large-mouth stomach worms, bots, lungworms, summer sores and cutaneous onchocerciasis.
Date of Approval: September 7, 2001

ANADA 200-322 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Butorphanol Tartrate, USP
Trade Name: Butorphanol Tartrate Injection
Indications for Use: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings.
Date of Approval: January 22, 2003

ANADA 200-323 original approval
Sponsor: West-Ward Pharmaceutical Corp.
Generic Name: Phenylbutazone Tablets
Trade Name: Phenylbutazone Tablets USP, 1 gram
Indications for Use: For relief of inflammatory conditions associated
with the musculoskeletal system in horses.
Date of Approval: March 28, 2003

ANADA 200-324 original approval
Sponsor: Veterinary Laboratories, Inc.
Generic Name: Dexamethasone Injection
Trade Name: Dexamethasone Injection 2 mg/mL
Indications for Use: Treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses.
Date of Approval: August 19, 2003

ANADA 200-326 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Ivermectin
Trade Name: BIMECTIN Paste 1.87%
Indications for Use: BIMECTIN Paste 1.87% provides effective treatment and control of the following parasites in horses: 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; Small Strongyles (adults, including those resistant to some benzimidizole class compounds) – 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; Small Stronglyes – Fourth-stage larvae; Pinworms (adults and fourthstage larvae) – Oxyuris equi; Ascarids (adults, thirdstage 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-stages 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: January 19, 2005

ANADA 200-326 supplemental approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Ivermectin
Trade Name: BIMECTIN Paste 1.87%
Effect of Supplement: This supplement provides for new indications for use claims no longer protected by a three-year exclusivity period that expired on April 2, 2006:   Large StrongylesCraterostomum acuticaudatum; Small StrongylesPetrovinema poculatum and Coronocyclus spp. including C. coronatus, and C. labratus. The generic labeling includes an additional indication for use claim for a parasite species not protected by exclusivity, C. labiatus.  This supplement also provides for revised packaging and minor label revisions.
Date of Approval: May 23, 2008

ANADA 200-327 original approval
Sponsor: First Priority, Inc.
Generic Name: Ivermectin liquid
Trade Name: Privermectin™ Drench for Sheep
Indications for Use: Treatment and control of gastrointestinal roundworms, lungworms, and nasal bots.
Date of Approval: May 15, 2002

ANADA 200-330 original approval
Sponsor: Altana Inc..
Generic Name: Nystatin, neomycin sulfate, thiostrepton, and triamcinolone acetonide
Trade Name: ANIMAX Cream
Indications for Use: Topical dermatologic disorders
characterized by inflammation and dry or exudative dermatitis, particularly associated with bacterial or candidal infections.
Date of Approval: September 4, 2003

ANADA 200-332 original approval
Sponsor: Lloyd, Inc.
Generic Name: Butorphanol tartrate
Trade Name: BUTORPHIC Injection
Indications for Use: Butorphic Injection is indicated for relief of pain associated with colic in adult horses and yearlings.  Clinical studies in the horse have shown that Butorphic Injection alleviates abdominal pain associated with torsion, impaction, intussusception, and tympanic colic, and postpartum pain.
Date of Approval: May 1, 2008

ANADA 200-333 original approval
Sponsor: Superior Equine Pharmaceuticals, Inc.
Generic Name: Phenylbutazone
Trade Name: SUPERIORBUTE
Indications for Use: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: April 20, 2007

ANADA 200-334 original approval
Sponsor: A & G Pharmaceuticals, Inc.
Generic Name: Phenylbutazone
Trade Name: EQUIZONE 100
Indications for Use: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: November 18, 2005

ANADA 200-338 original approval
Sponsor: Heska Corporation
Generic Name: Ivermectin/Pyrantel
Trade Name: TRI-HEART Plus (ivermectin/pyrantel) Chewable Tablets
Indications for Use: Prevents heartworm disease by eliminating the tissue stage of heartworm (Dirofilaria immitis) larvae for a month after infection and for the treatment and control of ascarids (Toxocara canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).
Date of Approval: August 13, 2003

ANADA 200-340 original approval
Sponsor: First Priority, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Privermectin ™ Pour-On for Cattle
Indications for Use: Treatment and control of gastrointestinal roundworms, lungworms, mites, cattle grubs, lice, and horn flies.
Date of Approval: December 4, 2002

ANADA 200-340 supplemental approval
Sponsor: First Priority, Inc.
Generic Name: Ivermectin
Trade Name: PRIVERMECTIN Pour-On for Cattle
Effect of Supplement: For adding the Material Safety Data Sheet (MSDS) information, removing the black box around the residue warning statement, adding the statement “Restricted Drug (California)-Use Only as Directed,” and adding the following under the persistent activity section:  “PRIVERMECTIN Pour-On has been proved to effectively control infections and to protect cattle from reinfection with:  Oesophagostomum radiatum and Dictyocaulus viviparus for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.”
Date of Approval: March 26, 2010

ANADA 200-341 original approval
Sponsor: Veterinary Laboratories, Inc.
Generic Name: Ivermectin
Trade Name: SparMectin-E
Indications for Use: For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, largemouth stomach worms, bots, lungworms and summer sores. Also treats cutaneous onchocerciasis.
Date of Approval: March 8, 2004

ANADA 200-341 supplemental approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Ivermectin
Trade Name: SparMectin-E
Indications for Use: This supplement provides for a change in preservative from benzyl alcohol to a combination of methylparaben and propylparaben, and a change in manufacturing process. In addition, product indications were updated to be consistent with the most recently approved labeling for the reference listed new animal drug (RLNAD).
Date of Approval: December 13, 2013

ANADA 200-342 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate paste
Trade Name: Pyrantel Pamoate Paste
Indications for Use: For the removal and control of mature infections of the following parasites: Large strongyles:Strongylus vulgaris, S. edentatus, S. equinus: Small strongyles; Pinworms: Oxyuris equi; Large roundworms; Parascaris equorum
Date of Approval: January 22, 2003

ANADA 200-342 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate
Trade Name: Pyrantel Pamoate Paste
Effect of Supplement: The supplement to NADA 200-342 provides revisions to 21 CFR 520.2044: Addition of label claim for the removal and control of mature infections of tapeworms (Anoplocephala perfoliata) in horses and ponies, with a single oral
dose of 6 milligrams pyrantel base per pound of body weight. The sponsor conducted effectiveness and target animal safety studies in support of this label claim; thus, this supplemental application is a submission under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. As a result, the application status of this supplemental approval for Pyrantel Pamoate Paste is designated NADA 200-342.
Date of Approval: April 18, 2005

ANADA 200-343 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate
Trade Name: Heifermax™ 500
Indications for Use: For heifers fed in confinement for slaughter – for increased weight gain, improved feed efficiency, and suppression of estrus (heat). For heifers intended for breeding – for suppression of estrus (heat).
Date of Approval: December 3, 2004

ANADA 200-344 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Tiamulin hydrogen fumarate
Trade Name: Tiamulin Soluble Antibiotic
Indications for Use: For the treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin and swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.
Date of Approval: February 16, 2005

ANADA 200-345 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Lincomycin hydrochloride monohydrate, spectinomycin dihydrochloride pentahydrate
Trade Name: Lincomycin - Spectinomycin
Indications for Use: For use in chickens up to 7 days of age as an aid in the control of air sacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin and Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin.
Date of Approval: February 5, 2004

ANADA 200-346 original approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component® TE-H
Indications for Use: For Increased rate of weight gain and improved feed efficiency for heifers fed in confinement for slaughter.
Date of Approval: September 27,2002

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component® TE-H with Tylan
Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® TE-H.
Date of Approval: April 18, 2003

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component® TE-IH
Effect of Supplement: This submission for Component® TE-IH for heifers is a supplement to the original ANADA 200-346 for Component® TE-H. Component® TE-IH is a lower dose of Component® TE-H with each pellet in Component® TE-IH (total of 4 pellets) containing 20 mg trenbolone acetate and 2 mg estradiol in the same formulation as each pellet in Component® TE-H (total of 7 pellets).
Date of Approval: August 19, 2003

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component ® TE-200
Effect of Supplement: Component® TE-200 for steers is a supplement to the original ANADA 200-346 for Component® TE-H. Component® TE-200 is a higher dose of Component® TEH, with each pellet in Component® TE-200 (a total of 10 pellets) containing 20 mg trenbolone acetate and 2 mg estradiol in the same formulation as each pellet in Component® TE-H (total of 7 pellets).
Date of Approval: April 21, 2003

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone acetate and estradiol, and tylosin tartrate
Trade Name: COMPONENT TE-IH with Tylan®
Indications for Use: For increased rate of weight gain.
Date of Approval: February 23, 2004

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-200 with TYLAN®
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-H, COMPONENT TE-IH, COMPONENT TE-H with TYLAN, and COMPONENT TE-IH with TYLAN
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone acetate and estradiol
Trade Name: COMPONENT TE-200
Effect of Supplement: This supplement provides for the addition of heifers to the label of Ivy Laboratories’ approved product COMPONENT TE-200 (trenbolone acetate and estradiol). The indications are for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter.
Date of Approval: January 14, 2005

ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-200 with TYLAN
Effect of Supplement: This supplement provides for the addition of a 29 mg tylosin tartrate pellet as a local antibacterial to COMPONENT TE-200 for use in steers and heifers fed in confinement for slaughter.
Date of Approval: January 26, 2007

ANADA 200-347 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Penicillin G Potassium USP Soluble Powder
Trade Name: Penicillin G Potassium USP Soluble Powder
Indications for Use: Penicillin G Potassium Soluble Powder is indicated in turkeys for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae.
Date of Approval: January 22, 2003

ANADA 200-348 original approval
Sponsor: ECO LLC
Generic Name: Ivermectin Topical Liquid
Trade Name: Ivermectin
Indications for Use: For treatment of gastrointestinal roundworms, lungworms, cattle grubs, mites, lice, and horn flies.
Date of Approval: November 15, 2002

ANADA 200-350 original approval
Sponsor: Cross Vetpharm Group Limited
Generic Name: Pyrantel Pamoate Oral Paste
Trade Name: Exodus™ (pyrantel pamoate) Paste
Indications for Use: Pyrantel pamoate paste is indicated for the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum) in horses and ponies.
Date of Approval: March 25, 2003