Animal & Veterinary

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 200-510 original approval
Sponsor: Pharmgate LLC
Generic Name: Chlortetracycline
Trade Name:Deracin®
Indications for Use: Calves (up to 250 lb): Increased rate of weight gain and improved feed efficiency.
Calves (250-400 lb): Increased rate of weight gain and improved feed efficiency.
Growing Cattle (over 400 lb): Increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses.
Beef Cattle: Control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.
Beef Cattle (under 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
Beef Cattle (over 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
Beef and Non-Lactating Dairy Cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
Calves, Beef, and Non-Lactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Swine: Control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.
Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
Increased rate of weight gain and improved feed efficiency.
Reduction in incidence of cervical lymphadenitis (jowl abscesses) caused by Group E. Streptococci susceptible to chlortetracycline.
Breeding Swine: Control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline.
Turkeys: Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.
Increased rate of weight gain and improved feed efficiency.
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.
Control of hexamitiasis caused by Hexamita meleagrides susceptible to Chlortetracycline.
Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.
Sheep: Increased rate of weight gain and improved feed efficiency.
Breeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline.
Ducks: Control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.
Chickens: Increased rate of weight gain and improved feed efficiency.
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline.
Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline.
Psittacine birds (parrots, macaws, cockatoos): Treatment of psittacine birds (parrots, macaws, cockatoos) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline..
Date of Approval: November 2, 2014

ANADA 200-512 original approval
Sponsor: Zoetis Inc.
Generic Name: Tiamulin hydrogen fumarate
Trade Name:Triamulox™
Indications for Use: Triamulox™, when administered in the drinking water for five consecutive days, is an effective antibiotic for the treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin at a dose level of 3.5 mg tiamulin hydrogen fumarate per pound of body weight daily and for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin when given at 10.5 mg tiamulin hydrogen fumarate per pound of body weight daily.
Date of Approval: November 7, 2014

ANADA 200-513 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Enrofloxacin
Trade Name: Enroflox™ Injection for Dogs 2.27%
Indications for Use: For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Date of Approval: May 8, 2014

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 200-520 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Carprofen
Trade Name: Carprieve® Injection
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: July 12, 2014

ANADA 200-522 original approval
Sponsor: Putney, Inc.
Generic Name: Carprofen
Trade Name: Carprofen Sterile Injectable Solution
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: October 15, 2014

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 200-527 original approval
Sponsor: Putney, Inc.
Generic Name: Enrofloxacin
Trade Name: Enrofloxacin Antibacterial Injectable Solution
Indications for Use: For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Date of Approval: January 9, 2015

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 200-530 original approval
Sponsor: Huvepharma AD
Generic Name: Ractopamine hydrochloride and tylosin phosphate
Trade Name: Paylean® plus Tylovet®
Indications for Use: Ractopamine hydrochloride 4.5 to 9.0 g/ton and tylosin phosphate 40 to 100 g/ton for 2 to 6 weeks immediately after medicating with 250 mg tylosin tartrate (as Tylan® Soluble) per gallon in drinking water for 3 to 10 days: 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; for treatment and control of swine dysentery associated with Brachyspira hyodysenteriae; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
Ractopamine hydrochloride 4.5 to 9.0 g/ton and tylosin phosphate 100 g/ton for at least 3 weeks followed by 40 g/ton until market weight: 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; for control of swine dysentery associated with Brachyspira hyodysenteriae; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
Ractopamine hydrochloride 4.5 to 9.0 g/ton and tylosin phosphate 100 g/ton: 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; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
Date of Approval: May 21, 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 200-540 original approval
Sponsor: Putney, Inc.
Generic Name: Meloxicam
Trade Name: Meloxicam Solution for Injection
Indications for Use: Dogs: 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: September 21, 2014

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 200-557 original approval
Sponsor: Putney, Inc.
Generic Name: Tiletamine hydrochloride and Zolazepam Hydrochloride
Trade Name: Tiletamine-Zolazepam
Indications for Use: Tiletamine-Zolazepam is indicated in cats for restraint or for anesthesia combined with muscle relaxation and in dogs for restraint and minor procedures of short duration (30 min. avg.) requiring mild to moderate analgesia.
Date of Approval: March 26, 2015

ANADA 200-558 original approval
Sponsor: Zoetis Inc.
Generic Name: Ractopamine hydrochloride plus tylosin phosphate
Trade Name: Engain™ plus Tylan®
Indications for Use: Ractopamine hydrochloride (4.5 to 9.0 g/ton) in combination with tylosin phosphate (40 or 100 g/ton): 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; for control of swine dysentery associated with Brachyspira hyodysenteriae; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
Ractopamine hydrochloride (4.5 to 9.0 g/ton) in combination with tylosin phosphate (100 g/ton): 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; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
Ractopamine hydrochloride (4.5 to 9.0 g/ton) in combination with tylosin phosphate (40 to 100 g/ton): 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; for treatment and control of swine dysentery associated with Brachyspira hyodysenteriae; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
Date of Approval: May 29, 2014

ANADA 200-559 original approval
Sponsor: Zoetis Inc.
Generic Name: Ractopamine hydrochloride plus monensin USP
Trade Name: Actogain™ 45 plus Rumensin®
Indications for Use: Ractopamine hydrochloride (8.2 to 24.6 g/ton) in combination with monensin USP (10 to 40 g/ton): 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.
Ractopamine hydrochloride (9.8 to 24.6 g/ton) in combination with monensin, USP (10 to 40 g/ton): 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.
Ractopamine (not to exceed 800 g/ton) in combination with a complete feed containing monensin USP (10 to 40 g/ton): For increased rate of weight gain and improved feed efficiency, 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.
Date of Approval: July 18, 2014

ANADA 200-560 original approval
Sponsor: Zoetis Inc.
Generic Name: Ractopamine hydrochloride plus monensin USP plus melengestrol acetate
Trade Name: Actogain™ 45 plus Rumensin® 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 suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: June 2, 2014

ANADA 200-561 original approval
Sponsor: Zoetis Inc.
Generic Name: Ractopamine hydrochloride, monensin USP, and tylosin phosphate
Trade Name: Actogain™ 45 plus Rumensin® plus Tylan®
Indications for Use: Ractopamine hydrochloride (8.2 to 24.6 g/ton) in combination with monensin sodium (10 to 40 g/ton) and tylosin phosphate (8 to 10 g/ton): 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.
Ractopamine hydrochloride (9.8 to 24.6 g/ton) in combination with monensin sodium (10 to 40 g/ton) and tylosin phosphate (8 to 10 g/ton): 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.
Ractopamine hydrochloride top dress (not to exceed 800g/ton) plus monensin sodium (10 to 40 g/ton) in combination with tylosin phosphate (8 to 10 g/ton): For increased rate of weight gain, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction in incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Date of Approval: May 30, 2014

ANADA 200-562 original approval
Sponsor: Zoetis Inc.
Generic Name: Ractopamine hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate
Trade Name: Actogain™ 45 plus Rumensin® plus Tylan® 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, 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 28 to 42 days on feed.
Date of Approval: June 2, 2014

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

ANADA 200-566 original approval
Sponsor: Huvepharma AD
Generic Name: Ractopamine hydrochloride, monensin USP, and tylosin phosphate
Trade Name: Optaflexx™ 45 plus Rumensin® plus Tylovet® 100
Indications for Use: Ractopamine hydrochloride (8.2 to 24.6 g/ton) in combination with monensin USP (10 to 40 g/ton) and tylosin phosphate (8 to 10 g/ton): 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.
Ractopamine hydrochloride (9.8 to 24.6 g/ton) in combination with monensin USP (10 to 40 g/ton) and tylosin phosphate (8 to 10 g/ton): 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.
Ractopamine hydrochloride top dress (not to exceed 800 g/ton) plus monensin USP (10 to 40 g/ton) in combination with tylosin phosphate (8 to 10 g/ton): 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 during the last 28 to 42 days on feed.
Date of Approval: July 27, 2014

ANADA 200-567 original approval
Sponsor: Huvepharma AD
Generic Name: Ractopamine hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate
Trade Name: Optaflexx™ 45 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, reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes, and suppression of estrus (heat) in cattle (heifers) fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: July 18, 2014

ANADA 200-569 original approval
Sponsor: Huvepharma AD
Generic Name: Tylosin phosphate and salinomycin sodium
Trade Name: Tylan® plus Sacox®
Indications for Use: For increased rate of weight gain and improved feed efficiency, and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati in broiler chickens.
Date of Approval: July 12, 2014

ANADA 200-570 original approval
Sponsor: Huvepharma AD
Generic Name: Tylosin phosphate and salinomycin sodium
Trade Name: Tylovet®100 plus Bio-cox®
Indications for Use: For increased rate of weight gain and improved feed efficiency, and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati in broiler chickens.
Date of Approval: July 12, 2014

ANADA 200-573 original approval
Sponsor: Putney, Inc.
Generic Name: Dexmedetomidine HCl
Trade Name: Dexmedetomidine hydrochloride
Indications for Use: For use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. Dexmedetomidine HCl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats.
Date of Approval: November 4, 2014

ANADA 200-575 original approval
Sponsor: Putney, Inc.
Generic Name: Carprofen
Trade Name: Carprofen Chewable Tablets
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.
Date of Approval: December 17, 2014

ANADA 200-576 original approval
Sponsor: Akorn Animal Health, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Gentamicin Sulfate Ophthalmic Solution
Indications for Use: For the topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats.
Date of Approval: January 30, 2015

ANADA 200-578 original approval
Sponsor: Belcher Pharmaceuticals, LLC
Generic Name: Carprofen
Trade Name: Carprofen Flavored Tablets
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: March 25, 2015

ANADA 200-579 original approval
Sponsor: Ceva Sante Animale
Generic Name: Altrenogest
Trade Name: Altrenogest Solution
Indications for Use: Altrenogest Solution is indicated for synchronization of estrus in sexually mature gilts that have had at least one estrus cycle. Treatment with altrenogest solution 0.22% results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period.
Date of Approval: April 16, 2015

ANADA 200-580 original approval
Sponsor: Huvepharma AD
Generic Name: Tylosin phosphate and salinomycin sodium
Trade Name: Tylovet® 100 plus Sacox®
Indications for Use: For increased rate of weight gain and improved feed efficiency, and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati in broiler chickens.
Date of Approval: May 1, 2015

ANADA 200-581 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Flunixin meglumine
Trade Name: Flunazine®
Indications for Use: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Date of Approval: October 14, 2014

Page Last Updated: 06/04/2015
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