200-351 to 200-500

ANADA 200-351 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Lincomycin Hydrochloride monohydrate
Trade Name: Lincomycin Injectable, USP
Indications for Use: For the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides such as Staphylococci, Streptococci, Erysipelothrix and Mycoplasma spp. It is also indicated for the treatment of mycoplasma pneumonia.
Date of Approval: February 13, 2004

ANADA 200-352 original approval
Sponsor: First Priority, Inc.
Generic Name: Pyrantel pamoate
Trade Name: PRIMEX Canine-2X and PRIMEX Canine
Indications for Use: For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. To prevent reinfestation of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
Date of Approval: August 20, 2003

ANADA 200-353 original approval
Sponsor: First Priority, Inc.
Generic Name: Pyrantel pamoate
Trade Name: PRIMEX Equine
Indications for Use: For the removal and control of mature large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pin worms (Oxyuris equi); large roundworms (Parascaris equorum) and small strongyles in horses and ponies.
Date of Approval: August 19, 2003

ANADA 200-354 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline, Monesin sodium
Trade Name: Pennchlor™ (Pennfield Oil Co.), Coban®(Elanco Animal Health, Inc.)
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: August 15, 2003

ANADA 200-355 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline
Trade Name: Pennchlor™, 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 chlortetracycline.
Date of Approval: March 31, 2003

ANADA 200-356 original approval
Sponsor: Pennfield Oil Co.
Generic Name: Chlortetracycline hydrochloride, tiamulin hydrogen fumarate
Trade Name: Pennchlor™ & Denagard®
Indications for Use: For treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline, and control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin.
Date of Approval: April 06, 2004

ANADA 200-357 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline, Salinomycin sodium
Trade Name: Pennchlor. (Pennfield Oil Co.), Bio-Cox® (Alpharma, Inc)
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: August 19, 2003

ANADA 200-358 original approval
Sponsor: Pennfield Oil Co.
Generic Name: Chlortetracycline hydrochloride, bacitracin methylene disalicylate
Trade Name: Pennfield Oil Co.
Indications for Use: For increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
Date of Approval: July 2, 2004

ANADA 200-359 original approval
Sponsor: Pennfield Oil Compnay
Generic Name: Chlortetracycline, decoquinate
Trade Name: Pennchlor™ / Deccox®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: March 19, 2004

ANADA 200-360 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Tiamulin hydrogen fumarate
Trade Name: Tiamulin Liquid Concentrate
Indications for Use: For the treatment of swine dysentery associated with Brachyspira hyodysenteriae and swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.
Date of Approval: June 24, 2005

ANADA 200-361 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Acepromazine maleate
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: April 14, 2004

ANADA 200-362 original approval
Sponsor: First Priority, Inc.
Generic Name: Miconazole nitrate
Trade Name: PRICONAZOLE Lotion, 1%; PRICONAZOLE Spray, 1%
Indications for Use: PRICONAZOLE (miconazole nitrate) Lotion, 1% and Spray, 1% are indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.
Date of Approval: November 14, 2005

ANADA 200-364 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Spectinomycin dihydrochloride pentahydrate
Trade Name: SYNOVEX
Indications for Use: For the treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin
Date of Approval: July 29, 2004

ANADA 200-365 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Glycopyrrolate, USP
Trade Name: Glycopyrrolate Injectable 0.2 mg/mL
Indications for Use: As a preanesthetic anticholinergic agent in dogs and cats
Date of Approval: October 2, 2006

ANADA 200-366 original approval
Sponsor: IMPAX Laboratories, Inc.
Generic Name: Carprofen
Trade Name: Carprofen Caplets
Indications for Use: For the relief of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: April 27, 2005

ANADA 200-366 supplemental approval
Sponsor: Impax Laboratories, Inc.
Generic Name: Carprofen
Trade Name: Novox® Caplets
Effect of Supplement: This application provides for the additional indication for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
Date of Approval: July 27, 2006

ANADA 200-367 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Trenbolone acetate and estradiol
Trade Name: SYNOVEX T40; SYNOVEX T80; SYNOVEX T120
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 200-368 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Lincomycin hydrochloride
Trade Name: LincoMed™ 100, LincoMed™ 300
Indications for Use: For the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides in swine, such as, staphylococci, streptococci, Erysipelothrix and Mycoplasma spp. It is also indicated for the treatment of mycoplasma pneumonia.
Date of Approval: August 2, 2006

ANADA 200-371 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Phenylbutazone
Trade Name: Phenylbutazone 20% Injection
Indications for Use: For relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: July 8, 2005

ANADA 200-373 original approval
Sponsor: First Priority, Inc.
Generic Name: Furosemide
Trade Name: Furosemide Syrup 1%
Indications for Use: A diuretic-saluretic for oral use alone or in combination with Furosemide Injection in the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
Date of Approval: November 18, 2005

ANADA 200-374 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Tetracycline hydrochloride
Trade Name: TETRAMED 324 HCA
Indications for Use: For use in the control and treatment of the following conditions in swine, calves, and poultry.
Swine and Calves: Use for the control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., and Klebsiella spp. sensitive to tetracycline hydrochloride.
Chickens: Use for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae sensitive to tetracycline hydrochloride.
Turkeys: Use for the control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms susceptible to tetracycline hydrochloride.
Date of Approval: September 13, 2005

ANADA 200-375 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate, monensin sodium, tylosin phosphate
Trade Name: Heifermax 500, Rumensin, Tylan
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes, and the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in heifers being fed in confinement for slaughter.
Date of Approval: September 19, 2005

ANADA 200-376 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Sodium sulfadimethoxine
Trade Name: SULFAMED-G Soluble Powder
Indications for Use: For Broiler and Replacement Chickens Only: Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
For Meat-producing Turkeys Only: Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.
For Dairy Calves, Dairy Heifers, and Beef Cattle: Use for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: November 14, 2005

ANADA 200-377 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Lincomycin hydrochloride
Trade Name: Lincomed 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.
Date of Approval: December 6, 2004

ANADA 200-378 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Neomycin sulfate
Trade Name: Neomycin Sulfate 325
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate. For the control of mortality associated with Escherichia coli organisms susceptible to neomycin sulfate in growing turkeys.
Date of Approval: August 31, 2006

ANADA 200-379 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Neomycin sulfate
Trade Name: NEOMYCIN Liquid
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep, and goats.
Date of Approval: October 24, 2006

ANADA 200-380 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate
Trade Name: SPECLINX-50
Indications for Use: For use in chickens up to 7 days of age as an aid in the control of: Airsacculitis 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 lincomycinspectinomycin.
Date of Approval: June 7, 2005

ANADA 200-382 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Furosemide
Trade Name: Furosemide Syrup 1%
Indications for Use: A diuretic-saluretic for oral use alone or in combination with furosemide Injection in the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
Date of Approval: November 18, 2004

ANADA 200-383 original approval
Sponsor: Novopharm Ltd.
Generic Name: Clindamycin hydrochloride
Trade Name: CLINDAROBE Capsules
Indications for Use: CLINDAROBE Capsules is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
Dogs: Skin infections (wounds and abscesses) due to coagulase-positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius). Deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens. Dental infections due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens.
Date of Approval: December 19, 2007

ANADA 200-386 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Levamisole hydrochloride
Trade Name: Levamisole Hydrochloride Soluble Drench Powder
Indications for Use: Levamisole hydrochloride is a broad spectrum anthelmintic and is effective against the following adult nematode infections in cattle and sheep Sheep: Stomach Worms: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta. Intestinal Worms: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina Lungworms: Dictyocaulus filariaCattle: Stomach Worms: Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei Intestinal Worms:Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum Lungworms: Dictyocaulus viviparus
Date of Approval: December 17, 2004

ANADA 200-387 supplemental approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Flunixin meglumine
Trade Name: FLUNAZINE
Indications for Use: Horses: FLUNAZINE Injectable Solution is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. Cattle: FLUNAZINE Injectable Solution is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia, and acute bovine mastitis. FLUNAZINE Injectable Solution is also indicated for control of inflammation in endotoxemia.
Date of Approval: December 18, 2008

ANADA 200-387 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Flunixin meglumine
Trade Name: FLUNAZINE
Indications for Use: Horse: recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.
Cattle: indicated for the control of pyrexia associated with bovine respiratory disease and endotoxemia. Flunixin Meglumine Injection is also indicated for the control of inflammation in endotoxemia.
Date of Approval: March 2, 2006

ANADA 200-388 original approval
Sponsor:  American Pharmaceuticals & Cosmetics, Inc.
Generic Name:  Gentamicin sulfate and betamethasone valerate
Trade Name:  GB Topical Spray
Indications for Use:  For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Date of Approval:  April 7, 2009

ANADA 200-389 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Amprolium
Trade Name: Amprolium 9.6% Oral Solution
Indications for Use: As an aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii.
Date of Approval: September 6, 2006

ANADA 200-390 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin
Trade Name: Ivermectin Paste 1.87%
Indications for Use: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Ivermectin Paste 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 benzimidizole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyanthostomum 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: June 20, 2006

ANADA 200-391 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Griseofulvin
Trade Name: Griseofulvin Powder Microsize
Indications for Use: Equine – Ringworm infection caused by Trichophyton equinum or Microsporum gypseum.
Date of Approval: June 1, 2006

ANADA 200-394 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Gentamicin Piglet Injection
Indications for Use: For the treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin
Date of Approval: November 17, 2006

ANADA 200-395 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Gentamicin sulfate solution
Indications for Use: Recommended for the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conceptions in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: July 31, 2006

ANADA 200-398 original approval
Sponsor: First Priority, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clindamycin Hydrochloride Oral Drops
Indications for Use: Clindamycin Hydrochloride Oral Drops (for use in dogs and cats) is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
Dogs: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or Staphyloccus intermedius). Deep wounds and abscesses due
to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens. Dental infections due to S. auerus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. Osteomyelitis due to S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius and Streptococcus spp. Deep wounds and infections due to Clostridium perfringens and Bacteroides fragilis. Dental infections due to S. aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis.
Date of Approval: March 19, 2007

ANADA 200-407 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Lincomycin hydrochloride/spectinomycin dihydrochloride pentahydrate
Trade Name: Lincomycin-Spectinomycin Water Soluble Powder
Indications for Use: For use in chickens up to 7 days of age as an aid in the control of airsacculitis 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: November 9, 2006

ANADA 200-408 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Butorphanol tartrate
Trade Name: Butorphanol Tartrate Injection (2mg/mL)
Indications for Use: Indicated for the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Date of Approval: April 20, 2007

ANADA 200-415 original approval
Sponsor: First Priority, Inc.
Generic Name: Gentamicin sulfate, betamethasone valerate
Trade Name: Gentamicin Sulfate Topical Spray
Indications for Use: For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Date of Approval: January 12, 2007

ANADA 200-418 original approval
Sponsor: Altana Inc.
Generic Name: Mupirocin
Trade Name: MURICIN Ointment 2%
Indications for Use: MURICIN Ointment 2% is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.
Date of Approval: March 8, 2007

ANADA 200-420 original approval
Sponsor: Cephazone Pharma, LLC
Generic Name: ceftiofur sodium
Trade Name: Ceftiofur Sodium Sterile Powder
Indications for Use: The treatment of various bacterial diseases in dogs, horses, cattle, swine, sheep, goats, day-old chickens, and day-old turkey poults.
Date of Approval: May 27, 2009

ANADA 200-422 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate, monensin sodium
Trade Name: HEIFERMAX 500, RUMENSIN
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in heifers being fed in confinement for slaughter.
Date of Approval: March 22, 2006

ANADA 200-424 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate, ractopamine hydrochloride, monensin sodium, and tylosin phosphate
Trade Name: HEIFERMAX 500, OPTAFLEXX, RUMENSIN, and TYLAN
Indications for Use: For suppression of estrus (heat), increased rate of weight gain, improved feed efficiency, increased leanness, the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers being fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: April 27, 2006

ANADA 200-424 supplemental approval
Sponsor: Ivy Laboratories
Generic Name: Ractopamine hydrochloride, monensin sodium, tylosin phosphate, and melengestrol acetate
Trade Name: OPTAFLEXX, RUMENSIN, TYLAN, and HEIFERMAX 500
Indications for Use: This supplement provides for an increase in the upper dose limit of monensin to 40 g/ton in the combined use of ractopamine hydrochloride, monensin sodium, tylosin phosphate and melengestrol acetate Type A medicated articles, based on the December 1, 2006, supplemental approval for RUMENSIN (under NADA 095-735). This supplement also updates the name of one of tylosin’s targeted bacteria to Arcanobacterium (Actinomyces) pyogenes, based on the November 7, 2006, supplemental approval for TYLAN (under NADA 012-491). In addition, this supplement references an increased monensin tolerance in cattle liver from 0.05 to 0.10 ppm, based on the September 11, 2007, supplemental approval for OPTAFLEXX plus RUMENSIN plus TYLAN plus MGA (under NADA 141-233).
Date of Approval: November 13, 2008

ANADA 200-425 original approval
Sponsor: First Priority, Inc.
Generic Name: nitrofurazone
Trade Name: Nitrofurazone Soluble Dressing
Indications for Use: For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers.
Date of Approval: July 13, 2009

ANADA 200-427 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate, tylosin phosphate
Trade Name: HEIFERMAX 500, TYLAN
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers being fed in confinement for slaughter.
Date of Approval: April 19, 2006

ANADA 200-430 original approval
Sponsor: Ivy Laboratories,
Generic Name: Melengestrol acetate, lasalocid sodium, tylosin phosphate
Trade Name: HEIFERMAX 500, BOVATEC, TYLAN
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers being fed in confinement for slaughter.
Date of Approval: June 1, 2006

ANADA 200-434 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Sodium sulfamethazine
Trade Name: SMZ-MED 454 Soluble Powder
Indications for Use: For treatment and control of disease caused by organisms sensitive to sulfamethazine: Beef and nonlactating dairy cattle: Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours)(Escherichia coli), necrotic pododermatitis (foot rot)(Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.). Swine: Treatment of porcine colibacillosis (bacterial scours) (Escherichia coli), and bacterial pneumonia (Pasteurella spp.). Chickens and turkeys. In chickens for control of infectious coryza (Haemophilus gallinarum), coccidiosis (Eimeria tenella, Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella pullorum). In turkeys for control of coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides).
Date of Approval: November 3, 2006

ANADA 200-435 original approval
Sponsor: Modern Veterinary Therapeutics, LLC
Generic Name: Doxapram hydrochloride
Trade Name: RESPIRAM
Indications for Use: For dogs, cats and horses: To stimulate respirations during and after general anesthesia. To speed awakening and return of reflexes after anesthesia. For neonate dogs and cats: Initiate respirations following cesarean section or dystocia. To stimulate respirations following dystocia or cesarean section.
Date of Approval: November 21, 2006

ANADA 200-436 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin and Clorsulon
Trade Name: NOROMECTIN Plus Injection for Cattle
Indications for Use: NOROMECTIN Plus Injection for Cattle is indicated for the effective treatment and control of the following parasites in cattle:
Gastrointestinal Roundworms (adults and fourth-stage larvae):
Ostertagia ostertagi (including inhibited O. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Oesophagostomum radiatum
Lungworms (adults and fourth-stage larvae):
Dictyocaulus viviparus
Liver Flukes:
Fasciola hepatica (adults only)
Cattle Grubs (parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mange Mites (cattle scab):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis
Persistent Activity
Ivermectin and clorsulon injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei, Cooperia punctata for 21 days after treatment; Haemonchus placei and Cooperia oncophora for 14 days after treatment.
Date of Approval: April 23, 2007

ANADA 200-437 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: NOROMECTIN Injection for Cattle and Swine
Indications for Use: Cattle: NOROMECTIN Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in cattle:
Gastrointestinal Roundworms (adults and fourth-stage larvae):
Ostertagia ostertagi (including inhibited O. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Oesophagostomum radiatum
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Lungworms (adults and fourth-stage larvae):
Dictyocaulus viviparus
Cattle Grubs (parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mites (scabies):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis
Persistent Activity
Ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus for 28 days after treatment; Ostertagia ostertagi for 21 days after treatment; Oesophagostomum radiatum, Haemonchus placei, Trichostrongylus axei, Cooperia punctata and Cooperia oncophora for 14 days after treatment.
Swine: NOROMECTIN Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine:
Gastrointestinal Roundworms:
Large roundworm, Ascaris suum
(adults and fourth-stage larvae)
Red stomach worm, Hyostrongylus rubidus
(adults and fourth-stage larvae)
Nodular worm, Oesophagostomum spp.
(adults and fourth-stage larvae)
Threadworm, Strongyloides ransomi (adults)
Somatic Roundworm Larvae:
Threadworm, Strongyloides ransomi (somatic larvae). Sows must be treated at least seven days before farrowing to prevent infection in piglets.
Lungworms:
Metastrongylus spp.(adults)
Lice:
Haematopinus suis
Mange mites:
Sarcoptes scabiei var. suis
Special Minor Use:
NOROMECTIN Injection is indicated for the effective treatment and control of warbles (Oedemagena tarandi) in reindeer. Follow use directions for cattle as described under Administration
NOROMECTIN Injection is indicated for the effective treatment and control of grubs (Hypoderma bovis) in American bison. Follow use directions for cattle as described under Administration.
Date of Approval: April 20, 2007

ANADA 200-437 supplemental approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: NOROMECTIN Injection for Cattle and Swine
Effect of Supplement: This supplement provides for extension of persistent effect indications as claimed by thepioneer sponsor. Specifically, the package insert has been revised as follows: Persistent activity against Oesophagostomum radiatumchanged from 14 to 28 days and that of Trichostrongylus axei and Cooperia punctatafrom 14 to 21 days.
Date of Approval: October 5, 2007

ANADA 200-438 original approval
Sponsor: Minrad, Inc.
Generic Name: Sevoflurane
Trade Name: PETREM
Indications for Use: PETREM is indicated for induction and maintenance of general anesthesia in dogs.
Date of Approval: April 3, 2008

ANADA 200-445 supplemental approval
Sponsor: First Priority, Inc.
Generic Name: Pyrantel pamoate
Trade Name: PRIMEX Equine Liquid Wormer
Effect of Supplement: 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: November 3, 2006

ANADA 200-448 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate, ractopamine hydrochloride, and monensin sodium
Trade Name: HEIFERMAX 500, OPTAFLEXX, and RUMENSIN
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 28 to 42 days on feed.
Date of Approval: January 29, 2007

ANADA 200-451 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate and lasalocid sodium
Trade Name: HEIFERMAX 500 and BOVATEC
Indications for Use: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) in heifers fed in confinement for slaughter.
Date of Approval: March 12, 2007

ANADA 200-452 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: OXYTET 10 Injection
Indications for Use: The use of OXYTET 10 Injection is indicated in beef cattle, beef calves, non-lactating dairy cattle and dairy calves for the treatment of the following disease conditions caused by one or more of the oxytetracycline sensitive pathogens listed as follows Bacterial Pneumonia and Shipping Fever Complex associated with Pasteurella spp.; Bacterial Enteritis (scours) caused by Escherichia coli; Necrotic Pododermatitis (Foot Rot) and Calf Diphtheria caused by Fusobacterium necrophorum; Wooden Tongue caused by Actinobacillus lignieresii; and Wound Infections, Acute Metritis and Traumatic Injury caused by susceptible strains of streptococcusand staphylococcus organisms.
Date of Approval: June 27, 2007

ANADA 200-460 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: TETROXY Aquatic
Indications for Use: To mark skeletal tissues, most often the otoliths, of all finfish fry and fingerlings for subsequent identification.
Date of Approval: April 20, 2007

ANADA 200-463 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Amprolium
Trade Name: Amprolium-P 9.6% Oral Solution
Indications for Use:  The treatment of coccidiosis in growing chickens, turkeys and laying hens.
Date of Approval: February 12, 2009

ANADA 200-476 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: flunixin meglumine
Trade Name: Flunixin Injection-S
Indications for Use: For the control of pyrexia associated with swine respiratory disease.
Date of Approval: June 22, 2009

ANADA 200-498 original approval
Sponsor:  Norbrook Laboratories, Ltd.
Generic Name:  Carprofen
Trade Name:  NOROCARP Caplets
Indications for Use:  For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.
Date of Approval: November 25, 2008

ANADA Public Master File (PMF) 5118
Sponsor: IR-4 project
Generic Name: fenbendazole
Trade Name: PANACUR
Indications for Use: For the removal and control of Haemonchus contortus and Ostertagia circumcincta in goats.
Date of Approval: April 25, 1994