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U.S. Department of Health and Human Services

Animal & Veterinary

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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 200-375 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate, monensin sodium, tylosin phosphate
Trade Name: Heifermax® 500 plus Rumensin® and Tylan®
Indications for Use: This supplement provides for an increase in the upper dose limit of monensin to 480 mg per head per day based upon the October 19, 2009, supplemental approval (NADA 138-870, C-0036) for Rumensin® and an update of the name of the tylosin targeted bacteria to Arcanobacterium pyogenes based on the November 7, 2006, approval (NADA 012-491,C-0318) for Tylan®.
Date of Approval: September 1, 2011

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 200-414 original approval
Sponsor: B.L. Mitchell, Inc.
Generic Name: Formalin
Trade Name: Formacide-B
Indications for Use: For use on all cultured finfish, penaeid shrimp and all finfish eggs.  Indications for use: 1. Parasiticide for Finfish:  for the control of external protozoa (Chilodonella spp., Costia spp., Epistylis spp., Ichthyophthirius spp., Scyphidia spp., and Trichodina spp.,), and the monogenetic trematode parasites (Cleidodiscus spp., Dactylogyrus spp., and Gyrodactylus spp.).
2. Parasiticide for Penaeid Shrimp:  for the control of external protozoan parasites (Bodo spp., Epistylis spp., and Zoothamnium spp.).
3. Fungicide for Finfish Eggs:  for the control of fungi of the family Saprolegniaceae.
Date of Approval: July 17, 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 200-416 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Gentamicin sulfate, betamethasone valerate
Trade Name: Gentamicin Topical Spray
Indications for Use: For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Date of Approval: November 10, 2011

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 200-421 original approval
Sponsor: Hospira, Inc.
Generic Name: ceftiofur sodium
Trade Name: Ceftiofur for Injection
Indications for Use:
Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Also, for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Swine: For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Sheep: For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Goats: For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Horses: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.Dogs: For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
Day-Old Chicks: For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
Day-Old Turkey Poults: For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults..
Date of Approval:
March 29, 2012

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 200-422 supplemental approval
Sponsor: Ivy Laboratories.
Generic Name: Melengestrol acetate, monensin sodium
Trade Name: HEIFERMAX 500, RUMENSIN
Indications for Use: This supplement provides for an increase in the upper dose limit of melengestrol acetate to 0.5 mg/hd/day and monensin sodium to 480 mg/hd/day based on the October 1, 2009, supplemental approval (NADA 125-476, C-0034) of MGA plus RUMENSIN 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: July 1, 2011

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 200-429 original approval
Sponsor:
Sparhawk Laboratories, Inc.
Generic Name: Ivermectin
Trade Name: Ivermectin Injection
Indications for Use: For the treatment and control of gastrointestinal roundworms, lungworms, lice and mange mites in cattle and swine.
Date of Approval: March 26, 2010

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 200-432 original approval
Sponsor:
Bioniche Animal Health USA, Inc.
Generic Name: Hyaluronate sodium
Trade Name: NexHA™
Indications for Use: Treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.
Date of Approval: October 18, 2013

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 200-441 original approval
Sponsor:
Alpharma Inc.
Generic Name: Chlortetracycline hydrochloride
Trade Name:
A-MYCIN Soluble Powder
Indications for Use:
For the control of infectious synovitis caused by Mycoplasma synoviae, Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasma gallisepticum and Escherichia coli, and mortality due to fowl cholera caused by Pasteurella multocida in chickens.  For the control of infectious synovitis caused by Mycoplasma synoviae and complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) in growing turkeys.  For the control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. in swine.  For the control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. in calves, beef cattle, and nonlactating dairy cattle.
Date of Approval:
October 9, 2009

ANADA 200-443 original approval
Sponsor: First Priority, Inc.
Generic Name:
Sulfadimethoxine
Trade Name:
Sulfadimethoxine Soluble Powder
Indications for Use:  
For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza in broiler and replacement chickens only; the treatment of coccidiosis and fowl cholera in meat-producing turkeys only; and 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 in dairy calves, dairy heifers and beef cattle.
Date of Approval: October 28, 2009

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 200-446 original approval
Sponsor: Modern Veterinary Therapeutics, LLC
Generic Name: Butorphanol tartrate, USP
Trade Name: BUTORPHINE Veterinary Injection
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: March 26, 2010

ANADA 200-447 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Ivermectin
Trade Name: Bimectin®
Indications for Use: Cattle: Bimectin® 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. punctataC. 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 proven 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, and Cooperia punctata for 21 days after treatment; and Haemonchus placei and Cooperia oncophora for 14 days after treatment.
Swine: Bimectin® 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 furrowing to prevent infection in piglets.
Lungworms: Metastrongylus spp. (adults)
Lice: Haematopinus suis
Mange Mites: Sarcoptes scabiei var. suis
Special Minor Use
Reindeer: For the treatment and control of warbles (Oedemagena tarandi).
American Bison: For the treatment and control of grubs (Hypoderma bovis).
Date of Approval: July 5, 2011

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 200-448 supplemental approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate, ractopamine hydrochloride, and monensin USP
Trade Name: HEIFERMAX 500, OPTAFLEXX and RUMENSIN
Effect of Supplement: For an increase in the upper dose limit of Type A medicated article RUMENSIN (monensin USP) from 30 g/ton to 40 g/ton for use in combination with OPTAFLEXX (ractopamine hydrochloride) and HEIFERMAX 500 (melengestrol acetate) for the manufacture of dry and liquid three-way combination Type C medicated feeds.
Date of Approval: February 16, 2010

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 200-455 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Tylosin tartrate
Trade Name: TyloMed-WS
Indications for Use: Chickens: As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of CRD associated with Mycoplasma gallisepticum sensitive to tylosin at the time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.
Turkeys: For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.
Swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae.
Honey Bees: For the control of American Foulbrood (Paenibacillus larvae).
Date of Approval: July 5, 2011

ANADA 200-455 supplemental approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Tylosin tartrate
Trade Name: TyloMed-WS
Effect of Supplement: To add indications to the product label for swine to include: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate Type A medicated article in feed, and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate Type A medicated article in feed.
Date of Approval: March 31, 2012

ANADA 200-457 original approval
Sponsor: Taro Pharmaceuticals U.S.A., Inc.
Generic Name: Mupirocin
Trade Name: Mupirocin Ointment USP, 2%
Indications for Use: Mupirocin ointment is indicated for the treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.
Date of Approval: November 29, 2010

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 200-464 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Amprolium
Trade Name: AMPROMED for Calves
Indications for Use: As an aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves.
Date of Approval: May 23, 2011

ANADA 200-466 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Ivermectin and clorsulon
Trade Name: SparMectin Plus Clorsulon
Indications for Use: SparMectin Plus Clorsulon is indicated for the effective treatment and control of the following parasites of 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
SparMectin Plus Clorsulon 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 and Cooperia punctata for 21 days after treatment; Haemonchus placei, and Cooperia oncophora for 14 days after treatment..
Date of Approval: September 4, 2012

ANADA 200-467 original approval
Sponsor:
Halocarbon Products Corp.
Generic Name:
Sevoflurane
Trade Name: Sevoflurane
Indications for Use: For induction and maintenance of general anesthesia in dogs.
Date of Approval: November 27, 2009

ANADA 200-468 original approval
Sponsor:
Cross Vetpharm Group Ltd.
Generic Name:
Gentamicin Sulfate, USP
Trade Name: GentaMed™-P for Poultry Injection
Indications for Use: Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.
Turkeys: As an aid in the prevention of early mortality of 1 to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.
Date of Approval: March 14, 2014

ANADA 200-473 original approval
Sponsor:
Huvepharma AD
Generic Name:
Tylosin tartrate
Trade Name: Pharmasin® Soluble
Indications for Use: Chickens: As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin at time of vaccination or other stress in chickens. For the control of chronic respiratory disease (CRD) associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.
Turkeys: For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.
Swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae.
Honey Bees: For the control of American Foulbrood (Paenibaccillus larvae).
Date of Approval: October 1, 2010

ANADA 200-473 supplemental approval
Sponsor: Huvepharma AD
Generic Name: Tylosin tartrate
Trade Name: Pharmasin® Soluble
Effect of Supplement: The effect of the supplement is to add new indications to the product labeling for swine to include: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate Type A medicated article in feed, and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate Type A medicated article in feed..
Date of Approval: March 13, 2012

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 200-478 original approval
Sponsor: Alpharma Inc.
Generic Name: Bacitracin zinc and nicarbazin
Trade Name: ALBAC 50 plus NICARB
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, E .brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: January 21, 2010

ANADA 200-479 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate plus zilpaterol hydrochloride and monensin USP
Trade Name: HEIFERMAX 500 plus ZILMAX 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 20 to 40 days on feed.
Date of Approval: December 30, 2009

ANADA 200-480 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate, zilpaterol hydrochloride, monensin USP, and tylosin phosphate
Trade Name: HEIFERMAX 500 plus ZILMAX, RUMENSIN and 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, 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: December 30, 2009

ANADA 200-481 original approval
Sponsor: Ceva Sante Animale
Generic Name: Altrenogest
Trade Name: ALTRESYN Solution 0.22%
Indications for Use: ALTRESYN (altrenogest) Solution 0.22% is indicated to suppress estrus in mares.  Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal.  This facilitates the attainment of regular cyclicity during the transition from winter anestrus to the physiological breeding season.  Suppression of estrus will also facilitate management of prolonged estrus conditions.  Suppression of estrus may be used to facilitate scheduled breeding during the physiological breeding season.
Date of Approval: April 20, 2012

ANADA 200-482 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Amprolium
Trade Name: AmproMed™ for Calves
Indications for Use: As an aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii in calves.
Date of Approval: July 29, 2012

ANADA 200-483 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate and zilpaterol hydrochloride
Trade Name: HEIFERMAX 500 plus ZILMAX
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and suppression of estrus (heat) in heifers fed in confinement for slaughter during the last 20 to 40 days on feed.
Date of Approval: December 30, 2009

ANADA 200-484 original approval
Sponsor: Huvepharma AD
Generic Name: Tylosin phosphate
Trade Name: Tylovet® 100
Indications for Use: Beef cattle: For reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes.
Chickens: For increased rate of weight gain and improved feed efficiency.
Laying chickens: For improved feed efficiency.
Broilers and replacement chickens: To aid in the control of chronic respiratory disease associated with Mycoplasma gallisepticum.
Swine: For increased rate of weight gain and improved feed efficiency, for maintaining weight gains and feed efficiency in the presence of atrophic rhinitis, for control of swine dysentery associated with Brachyspira hyodysenteriae, for the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin tartrate in drinking water, and for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis..
Date of Approval: February 15, 2012

ANADA 200-485 original approval
Sponsor:
Accord Healthcare, Inc.
Generic Name:
Meloxicam
Trade Name: Meloxicam Injection
Indications for Use: Dogs: Meloxicam Injection 5 mg/mL Solution for Injection is indicated for the control of pain and inflammation associated with osteoarthritis.
Cats: For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.
Date of Approval: December 21, 2012

ANADA 200-488 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Amprolium
Trade Name: AMPROMED P for Poultry
Indications for Use: Intended for the treatment of coccidiosis in growing chickens, turkeys, and laying hens.
Date of Approval: May 23, 2011

ANADA 200-489 original approval
Sponsor:
Cross Vetpharm Group Ltd.
Generic Name:
Flunixin meglumine
Trade Name: FLUNAZINE-S
Indications for Use: For the control of pyrexia associated with swine respiratory disease.
Date of Approval: March 1, 2010

ANADA 200-491 original approval
Sponsor:
Norbrook Laboratories, Ltd.
Generic Name:
Meloxicam
Trade Name: Loxicom®
Indications for Use: Loxicom® (meloxicam) 5 mg/mL Injectable sterile solution is indicated for the control of pain and inflammation associated with osteoarthritis in dogs and for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery in cats.
Date of Approval: December 19, 2012

ANADA 200-494 original approval
Sponsor:
Cross Vetpharm Group Ltd.
Generic Name:
Gentamicin sulfate
Trade Name: GentaMed™
Indications for Use: For the control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for the control and treatment of swine dysentery associated with Treponema hyodysenteriae.
Date of Approval: December 14, 2011

ANADA 200-495 original approval
Sponsor:
 Norbrook Laboratories, Ltd.
Generic Name:  Enrofloxacin
Trade Name:  ENROFLOX 100
Indications for Use: Cattle: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolitica, Pasturella multocida, and Histophilus somni in beef and non-lactating dairy cattle (multiple-day therapy).
Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
Date of Approval: February 28, 2013

ANADA 200-496 original approval
Sponsor:
Cross Vetpharm Group Ltd.
Generic Name:
Amprolium
Trade Name: AmproMed™ P for Poultry
Indications for Use: For the treatment of coccidiosis in growing chickens, turkeys, and laying hens.
Date of Approval: October 25, 2012

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