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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 200-531 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 200-541 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 200-543 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

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