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  1. Approved Animal Drug Products (Green Book)

Recent Animal Drug Approvals


Drug Approval Information

Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA 
Freedom of Information (FOI) Summaries for Approved New Animal Drugs (FOI Summary)
Environmental Assessments/Findings of No Significant Impact (EA/FONSI)
NSAID Labels
Medicated Feed (Blue Bird) Labels


Date Application Number Sponsor Product Name Species Indications for Use/Effect of the Supplement Public Documents
October 29, 2019 ANADA 200-635 Mizner Bioscience LLC Clomipramine Hydrochloride Tablets Dogs Clomipramine Hydrochloride Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. FOI Summary
October 11, 2019 ANADA 200-652 Huvepharma EOOD Deccox® and Monovet® Cattle fed in confinement for slaughter For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, and improved feed efficiency in cattle being fed in confinement for slaughter. FOI Summary
October 11, 2019 ANADA 200-653 Huvepharma EOOD Deccox® and Monovet® and Tylovet® Cattle fed in confinement for slaughter For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, for improved feed efficiency, and for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in
cattle fed in confinement for slaughter.
FOI Summary
October 11, 2019 ANADA 200-654 Huvepharma EOOD Tilmovet® and Monovet® Cattle fed in confinement for slaughter For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group. For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group. FOI Summary
October 11, 2019 ANADA 200-655 Huvepharma EOOD Pulmotil™ and Monovet® Cattle fed in confinement for slaughter For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group. For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group. FOI Summary
October 11, 2019 ANADA 200-656 Huvepharma EOOD Deccox® and Monovet® and Tylan™ Cattle fed in confinement for slaughter For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, for improved feed efficiency, and for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in
cattle fed in confinement for slaughter.
FOI Summary
October 11, 2019 ANADA 200-658 Huvepharma EOOD MGA® and Monovet® Heifers fed in confinement for slaughter Increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in heifers fed in confinement for slaughter. FOI Summary
October 11, 2019 ANADA 200-659 Huvepharma EOOD Actogain™ and Monovet® and MGA® Heifers fed in confinement for slaughter For increased rate of weight gain, improved feed efficiency, increased carcass leanness and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Heifers Fed in Confinement for Slaughter: For Increased Rate of Weight Gain, Improved Feed Efficiency and Suppression of Estrus (Heat).
FOI Summary
October 11, 2019 ANADA 200-660 Huvepharma EOOD MGA® and Monovet® and Tylovet® Heifers fed in confinement for slaughter 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. FOI Summary
October 11, 2019 ANADA 200-661 Huvepharma EOOD MGA® and Monovet® and Tylan™ Heifers fed in confinement for slaughter 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. FOI Summary
October 11, 2019 ANADA 200-662 Huvepharma EOOD Actogain™ and Monovet® Cattle fed in confinement for slaughter For increased rate of weight gain, improved feed efficiency and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
For increased rate of weight gain, improved feed efficiency, increased carcass leanness and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
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.
For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
FOI Summary
September 20, 2019 ANADA 200-642 Huvepharma EOOD Monovet® and Tylovet® Cattle fed in confinement for slaughter For improved feed efficiency and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter. For 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. FOI Summary
September 20, 2019 ANADA 200-643 Huvepharma EOOD     Monovet® and Tylan™ Cattle fed in confinement for slaughter For improved feed efficiency and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter. For 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. FOI Summary
September 20, 2019 ANADA 200-644 Huvepharma EOOD Optaflexx™and Monovet® and Tylovet® Cattle fed in confinement for slaughter 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.
For increased rate of weight gain, improved feed efficiency, 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 28 to 42 days on feed. 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 28 to 42 days on feed.
FOI Summary
September 20, 2019 ANADA 200-645 Huvepharma EOOD Actogain™ and Monovet® and Tylovet™ Cattle fed in confinement for slaughter 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.
For increased rate of weight gain, improved feed efficiency, 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 28 to 42 days on feed. 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 28 to 42 days on feed.
FOI Summary
September 20, 2019 ANADA 200-646 Huvepharma EOOD Optaflexx™ and Monovet® and Tylan™ Cattle fed in confinement for slaughter 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.
For increased rate of weight gain, improved feed efficiency, 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 28 to 42 days on feed. 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 28 to 42 days on feed.
FOI Summary
September 20, 2019 ANADA 200-647 Huvepharma EOOD Actogain™ and Monovet® and Tylan™ Cattle fed in confinement for slaughter 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.
For increased rate of weight gain, improved feed efficiency, 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 28 to 42 days on feed. 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 28 to 42 days on feed.
FOI Summary
September 20, 2019 ANADA 200-648 Huvepharma EOOD Optaflexx™ and Monovet® and Tylovet® and MGA® Heifers fed in confinement for slaughter 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 28 to 42 days on feed.
Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
FOI Summary
September 20, 2019 ANADA 200-649 Huvepharma EOOD Actogain™ and Monovet® and Tylovet® and MGA® Heifers fed in confinement for slaughter 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 28 to 42 days on feed.
Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
FOI Summary
September 20, 2019 ANADA 200-650 Huvepharma EOOD Optaflexx™ and Monovet® and Tylan™ and MGA® Heifers fed in confinement for slaughter 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 28 to 42 days on feed.
Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
FOI Summary
September 20, 2019 ANADA 200-651 Huvepharma EOOD Actogain™ and Monovet® and Tylan™ and MGA® Heifers fed in confinement for slaughter 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 28 to 42 days on feed.
Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
FOI Summary
September 3, 2019 NADA 141-494 Elanco US Inc. Credelio™ Dogs This supplement provides for the addition of the indication for the prevention of flea
infestations (Ctenocephalides felis) for one month in dogs and puppies 8 weeks of age and
older, and weighing 4.4 pounds or greater.
FOI Summary
August 27, 2019 NADA 141-465 Elanco US Inc. Inteprity™ and Coban™ Broiler chickens This supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days of age as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. FOI Summary
August 27, 2019 NADA 141-467 Elanco US Inc. Inteprity™ and Monteban™ Broiler chickens This supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days of age as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. FOI Summary
August 27, 2019 NADA 141-495 Elanco US Inc. Inteprity™ and Bio-Cox® Broiler chickens This supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days as follows: To assure reasonable antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.
 
FOI Summary
July 26, 2019 NADA 141-255 Syndel USA 35% PEROX-AID® Freshwater-reared finfish This supplement provides for the addition of the following indications:
For the control of mortality in freshwater-reared coldwater finfish, fingerling and adult freshwater-reared coolwater finfish, and fingerling and adult freshwater-reared warmwater finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae.
For the treatment and control of Gyrodactylus spp. in freshwater-reared salmonids.
For the control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare.
FOI Summary
July 5, 2019 NADA 113-645 Intervet, Inc. Estrumate® Lactating dairy cows This supplement provides for addition of the indication ‘For use with Fertagyl® (gonadorelin) to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows.’ FOI Summary
July 2, 2019 NADA 141-519 Zoetis Inc. ProHeart® 12 Dogs 1 year of age and older For use in dogs 12 months of age and older for the prevention of heartworm disease caused by Dirofilaria immitis for 12 months. For the treatment of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections. FOI Summary
July 1, 2019 ANADA 200-639 Huvepharma EOOD Monovet® 90 Cattle fed in confinement for slaughter, dairy cows, growing cattle on pasture or in dry lot (stocker and feeder and dairy and beef replacement heifers), mature reproducing beef cows, calves (excluding veal calves), and goats Cattle fed in confinement for slaughter: for improved feed efficiency; for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Dairy cows: for increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake). Growing cattle on pasture or in dry lot (stocker and feeder and dairy and beef replacement heifers): for increased rate of weight gain; for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Mature reproducing beef cows: for improved feed efficiency when receiving supplemental feed; for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Calves (excluding veal calves): for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Goats: for the prevention of coccidiosis caused by Eimeria crandallis, Eimeria christenseni, and Eimeria ninakohlyakimovae in goats maintained in confinement. FOI Summary
May 30, 2019 ANADA 200-537 Bimeda Animal Health Ltd. OxyMed™ LA Swine, beef cattle, dairy cattle, and calves including preruminating (veal) calves Cattle: For the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.
Swine: For the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows, OxyMed™ LA is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
FOI Summary
May 21, 2019 NADA 141-514 Elanco US Inc. Experior™ and Rumensin™ Beef steers and heifers fed in confinement for slaughter 1) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
2) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and improved feed efficiency in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
FOI Summary
May 21, 2019 NADA 141-512 Elanco US Inc. Experior™ and Rumensin™ and Tylan™ Beef steers and heifers fed in confinement for slaughter 1) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
2) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
FOI Summary
May 16, 2019 ANADA 200-598 Bimeda Animal Health Limited EnroMed™ 100 Cattle (beef and non-lactating dairy) and
swine
Cattle-Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.
Cattle-Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.
Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae, and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.
FOI Summary
May 7, 2019 ANADA 200-633 Pharmgate Inc. Denagard® and Deracin® Swine For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida sensitive to chlortetracycline. FOI Summary
May 6, 2019 NADA 141-288 Zoetis Inc. EXCENEL® RTU EZ Swine This supplement provides for an increase in the maximum injection site volume in swine from 5 mL to 15 mL. The larger maximum injection site volume will reduce the number of injections needed in larger pigs. FOI Summary