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U.S. Department of Health and Human Services

Animal & Veterinary

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200-501 to 200-650

ANADA 200-509 original approval
Sponsor: Huvepharma AD
Generic Name: Tilmicosin phosphate
Trade Name:Tilmovet® 90
Indications for Use: For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.
Date of Approval: February 21, 2013

ANADA 200-514 original approval
Sponsor: Phibro Animal Health Corp.
Generic Name: Amprolium
Trade Name: Boviprol™ 9.6% Oral Solution
Indications for Use: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves.
Date of Approval: August 15, 2013

ANADA 200-517 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Enrofloxacin
Trade Name: Zobuxa™
Indications for Use: For the management of diseases associated with bacteria susceptible to enrofloxacin.
Date of Approval: June 20, 2013

ANADA 200-519 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Florfenicol
Trade Name: Florvio™ 2.3% Concentrate Solution
Indications for Use: For the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis in swine.
Date of Approval: May 23, 2013

ANADA 200-523 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Sulfadimethoxine
Trade Name: SulfaMed™
Indications for Use: For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum sensitive to sulfadimethoxine.
Date of Approval: December 19, 2013

ANADA 200-524 original approval
Sponsor: Putney, Inc.
Generic Name: Mupirocin
Trade Name: Mupirocin Ointment 2%
Indications for Use: 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: June 24, 2013

ANADA 200-529 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Xylazine
Trade Name: XylaMed™
Indications for Use: XYLAMED should be used in horses and Cervidae (Fallow Deer, Mule Deer, Sika Deer, White-Tailed Deer, and Elk) when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.
Horses: XYLAMED has been used successfully as follows:
1. Diagnostic procedures-oral and ophthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations.
2. Orthopedic procedures, such as application of casting materials and splints.
3. Dental procedures.
4. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations.
5. To calm and facilitate handling of fractious animals.
6. Therapeutic medication for sedation and relief of pain following injury or surgery.
7. Major surgical procedures:
a. When used as a preanesthetic to general anesthesia.
b. When used in conjunction with local anesthetics.
Cervidae: XYLAMED may be used for the following:
1. To calm and facilitate handling of fractious animals.
2. Diagnostic procedures.
3. Minor surgical procedures.
4. Therapeutic medication for sedation and relief of pain following injury or surgery.
5. As a preanesthetic to local anesthesia.
XYLAMED at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine..
Date of Approval: March 14, 2014

ANADA 200-531 original approval
Sponsor: Huvepharma AD
Generic Name: Monensin USP plus tylosin phosphate
Trade Name:Rumensin® plus Tylovet® 100
Indications for Use: For improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and reduction of incidence of liver abscesses.
Date of Approval: February 1, 2013

ANADA 200-532 original approval
Sponsor: Huvepharma AD
Generic Name: Melengestrol acetate plus tylosin phosphate
Trade Name: MGA® plus Tylovet® 100
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 Arcanobacterium (Actinomyces) pyogenes in heifers fed in confinement for slaughter.
Date of Approval: March 7, 2013

ANADA 200-533 original approval
Sponsor: Huvepharma AD
Generic Name: Decoquinate plus monensin USP plus tylosin phosphate
Trade Name:Deccox® plus Rumensin® plus Tylovet® 100
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, for improved feed efficiency, and for reduction in the incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces pyogenes in growing-finishing cattle being fed in confinement for slaughter.
Date of Approval: March 14, 2013

ANADA 200-534 original approval
Sponsor: Huvepharma AD
Generic Name: Melengestrol acetate, monensin USP, tylosin phosphate
Trade Name: MGA® plus Rumensin® plus Tylovet® 100
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii, reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes in heifers fed in confinement for slaughter.
Date of Approval: November 30, 2012

ANADA 200-535 original approval
Sponsor: Huvepharma AD
Generic Name: Melengestrol acetate plus lasalocid sodium plus tylosin phosphate
Trade Name: MGA® plus Bovatec® plus Tylovet® 100
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: March 26, 2013

ANADA 200-538 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Clindamycin hydrochloride
Trade Name:ClindaMed™ Oral Drops
Indications for Use: 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.
Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp. Deep wounds and abscesses due to Clostridium perfringens and Bacteroides fragilis.
Dental infections due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp., Clostridium perfringens and Bacteroides fragilis.
Date of Approval: April 19, 2013

ANADA 200-541 original approval
Sponsor: Parnell Technologies Pty. Ltd.
Generic Name: gonadorelin acetate
Trade Name: GONABREED
Indications for Use: For the treatment of ovarian follicular cysts in dairy cattle. For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.
Date of Approval: January 17, 2013

ANADA 200-542 original approval
Sponsor: Zoetis Inc.
Generic Name: Ractopamine hydrochloride
Trade Name: Engain™ 9 and Engain™ 45
Indications for Use: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter.
Date of Approval: July 16, 2013

ANADA 200-543 original approval
Sponsor: Putney, Inc.
Generic Name: Cefpodoxime proxetil
Trade Name: Cefpodoxime Proxetil Tablets
Indications for Use: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis (group G, β hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.
Date of Approval: December 14, 2012

ANADA 200-544 original approval
Sponsor: Huvepharma AD
Generic Name: Zilpaterol hydrochloride plus monensin USP plus tylosin phosphate plus melengestrol acetate
Trade Name: Zilmax® plus Rumensin® plus Tylovet® 100 plus MGA®
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction 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: May 24, 2013

ANADA 200-547 original approval
Sponsor: Huvepharma AD
Generic Name: Zilpaterol hydrochloride plus monensin USP plus tylosin phosphate
Trade Name: Zilmax® plus Rumensin® plus Tylovet® 100
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: June 25, 2013

ANADA 200-548 original approval
Sponsor: Zoetis Inc.
Generic Name: Ractopamine hydrochloride
Trade Name: Actogain™ 45
Indications for Use: Complete Feed:
(8.2 – 24.6 g/ton) - For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
(9.8 – 24.6 g/ton) - For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Top Dress Feed:
(70-400 mg/head/day) – For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed..
Date of Approval: July 18, 2013

ANADA 200-550 original approval
Sponsor: Ceva Sante Animale
Generic Name: Meloxicam
Trade Name: Meloxidyl®
Indications for Use: For control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: August 2, 2013

ANADA 200-551 original approval
Sponsor: Putney, Inc.
Generic Name: Enrofloxacin
Trade Name: Enrofloxacin Flavored Tablets
Indications for Use: For the management of diseases associated with bacteria susceptible to enrofloxacin.
Date of Approval: April 19, 2013

ANADA 200-555 original approval
Sponsor: Piedmont Animal Health
Generic Name: Carprofen
Trade Name: Librevia™
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: June 13, 2013

ANADA 200-564 original approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: Ivermectin Paste 1.87%
Indications for Use: Ivermectin (ivermectin) Paste 1.87% provides effective treatment and control of the following parasites in horses.
• Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum;
• Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum;
• Small Strongyles - Fourth-stage larvae;
• Pinworms (adults and fourth-stage larvae) - Oxyuris equi;
• Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum;
• Hairworms (adults) - Trichostrongylus axei;
• Large-mouth Stomach Worms (adults) - Habronema muscae;
• Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis;
• Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi;
• Intestinal Threadworms (adults) - Strongyloides westeri;
• Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae;
• Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Date of Approval: December 23, 2013