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U.S. Department of Health and Human Services

Animal & Veterinary

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141-161 to 141-250

NADA 141-162 original approval
Sponsor: Wellmark International
Generic Name: (S)-Methoprene
Trade Name: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® FLEA CONTROL CAPSULES™
Indications for Use: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-Methoprene prevents and controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Date of Approval: January 24, 2000

NADA 141-163 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Solution
Trade Name: MILBEMITE™ OTIC Solution
Indications for Use: MILBEMITE OTIC Solution is indicated for treatment of ear mite (Otodectes cyanotis) infestations in cats and kittens eight weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.
Date of Approval: February 2, 2000

NADA 141-163 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Solution
Trade Name: MILBEMITE™ OTIC Solution
Effect of Supplement: This supplement provides target animal safety study data to lower the age limitation of the product from 8 to 4 week old kittens and to allow a repeat treatment if necessary.
Date of Approval: December 13, 2000

NADA 141-164 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin, Tylosin phosphate
Trade Name: COBAN®, TYLAN®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 3, 2000

NADA 141-170 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin, tylosin phosphate
Trade Name: Monteban® plus Tylan®
Indications for Use: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 20, 2000

NADA 141-171 original approval
Sponsor: Purina Mills, Inc.
Generic Name: Lasalocid
Trade Name: Bovatec® 68 Purina Sugar Mag Block 1440 BVT Medicated Mineral Block
Indications for Use: For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
Date of Approval: August 20, 2002

NADA 141-172 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, Tylosin phosphate
Trade Name: PAYLEAN®, TYLAN®
Indications for Use: 1) For increased weight gain, improved feed efficiency and increased carcass leanness in finishing swine fed a complete ration containing at least 16% crude protein from 150 lb (68kg) to 240 lb (109 kg) body weight, and for prevention and/or control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. 2) For improved feed efficiency and increased carcass leanness in finishing swine fed a complete ration containing at least 16% crude protein from 150 lb (68kg) to 240 lb (109 kg) body weight, and for prevention and/or control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis.
Date of Approval: February 20, 2001

NADA 141-172 supplemental approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, Tylosin phosphate
Trade Name: PAYLEAN®, TYLAN®
Effect of Supplement: To provide for the use of ractopamine and tylosin single-ingredient Type A medicated articles to make a combination drug type C medicated feed and to add the claim for the prevention of swine dysentery in finishing swine.
Date of Approval: June 19, 2002

NADA 141-172 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride and tylosin phosphate
Trade Name: PAYLEAN and TYLAN
Effect of Supplement: This supplement provides for the combined use of ractopamine hydrochloride and tylosin phosphate in swine in excess of 240 lb and
reduces the maximum dose of ractopamine hydrochloride to 10 ppm (9 g/ton).
Date of Approval: October 20, 2006

NADA 141-172 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride and tylosin phosphate
Trade Name: PAYLEAN plus TYLAN
Effect of Supplement: This supplement provides for revised indications for the combined use of ractopamine hydrochloride and tylosin phosphate in finishing swine, based on the November 13, 2008,  supplemental approval for TYLAN (under NADA 012-491), which added an alternate dosage and feeding regimen for the porcine proliferative enteropathies (PPE, ileitis) claim.  The new claim is:  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. This supplement also corrects the Type B and C medicated feed (Blue Bird) labeling for the control of swine dysentery and control of ileitis claim to reflect the two point dose approval (40 or 100 g/ton) for tylosin phosphate rather than the range of 40 to 100 g/ton erroneously codified in 21 CFR 558.625(f)(1)(vi)(b) for tylosin phosphate. 
Date of Approval: October 23, 2009

NADA 141-174 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Ivermectin otic suspension
Trade Name: ACAREXX™
Indications for Use: ACAREXX is indicated for the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age or older. Effectiveness against eggs and immature stages has not been proven.
Date of Approval: December 5 , 2000

NADA 141-175 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Nitenpyram
Trade Name: Capstar™
Indications for Use: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater.
Date of Approval: October 20, 2000

NADA 141-175 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Nitenpyram
Trade Name: Capstar™
Effect of Supplement: 1. The text in the “Indications” section is changed to include the words “kill adult fleas.” The section will now read: “CAPSTAR® Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs, puppies, cats and kittens 4 weeks of age and older and 2 pounds of body weight or greater.” This change makes the labeling more consistent with labeling for other approved products that kill adult fleas.
2. There are some minor revisions to clarify the currently approved text in the package insert and the unit dose cartons.
3. The package insert is revised to include reference to the concurrent use of PROGRAM® (lufenuron) Flavor Tabs® (NADA 141-035) to kill adult fleas and prevent flea eggs from hatching. The information supporting approval for this concurrent use is documented in NADA 141-205.
4. The package insert is revised to refer the reader to a veterinarian for information about the concurrent use of SENTINEL® (milbemycin oxime/lufenuron) Flavor Tabs® (NADA 141-084), to kill adult fleas and prevent flea eggs from hatching. SENTINEL® Flavor Tabs® are a prescription product. The information supporting approval for this concurrent use is documented in NADA 141-204.
5. The unit dose cartons are revised to refer to concurrent use with PROGRAM® (lufenuron) Flavor Tabs®. 6. Each unit dose carton will contain an additional “FLEA MANAGEMENT SYSTEMÔ” package insert that provides specific information for using CAPSTAR® Tablets with PROGRAM® (lufenuron) Flavor Tabs®.
Date of Approval: June 11, 2003

NADA 141-176 original approval
Sponsor: BAYER Corporation
Generic Name: Enrofloxacin/Silver Sulfadiazine
Trade Name: Baytril® Otic
Indications for Use: Baytril® Otic is indicated for the treatment of canine otitis externa complicated by acterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.
Date of Approval: September 29, 2000

NADA 141-177 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Gentamicin sulfate, Clotrimazole, Mometasone furoate monohydrate
Trade Name: Mometamax™ Otic Suspension
Indications for Use: Mometamax™ Otic Suspension is indicated for the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.
Date of Approval: December 5 , 2000

NADA 141-177 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Gentamicin sulfate, USP; mometasone furoate monohydrate; and clotrimazole, USP suspension
Trade Name: Mometamax™ Otic Suspension
Indications for Use: For the treament of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and certain bacteria (Pseudomonas supp. including P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci).
Date of Approval: January 9, 2003

NADA 141-177 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Gentamicin sulfate, USP; mometasone furoate monohydrate; and clotrimazole, USP suspension
Trade Name: MOMETAMAX
Effect of Supplement: New package size (7.5g bottle)
Date of Approval: June 1, 2005

NADA 141-178 original approval
Sponsor: IDEXX Pharmaceuticals, Inc.
Generic Name: Nitazoxanide
Trade Name: NAVIGATOR (32% nitazoxanide) Antiprotozoal Oral Paste
Indications for Use: NAVIGATOR (32% nitazoxanide) Antiprotozoal Oral Paste in indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.
Date of Approval: November 18, 2003

NADA 141-179 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium, Bacitracin methylene disalicylate
Trade Name: AVATEC®, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and
E. adenoeides, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: July 11, 2001

NADA 141-180 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Albuterol sulfate
Trade Name: Torpex™
Indications for Use: For the immediate relief of bronchospasm and bronchoconstriction associated with reversible airway obstruction in horses.
Date of Approval: November 16, 2001

NADA 141-181 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid, Bacitracin zinc
Trade Name: AVATEC, ALBAC
Indications for Use: For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: May 15, 2002

NADA 141-185 original approval
Sponsor: Alpharma, Inc.
Generic Name: decoquinate, chlortetracycline
Trade Name: Deccox® plus Aureomycin®
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 for bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: March 15, 2002

NADA 141-185 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: DECCOX AUREOMYCIN
Trade Name: Decoquinate Chlortetracycline
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 for bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: December 16, 2004

NADA 141-186 original approval
Sponsor: IDEXX Pharmaceuticals, Inc.
Generic Name: 1% diclofenac sodium
Trade Name: SURPASS
Indications for Use: SURPASS is indicated for the control of pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal (hock, knee, fetlock, and pastern) joints in horses.
Date of Approval: May 13, 2004

NADA 141-187 original approval
Sponsor: Ridley Block Operations Inc.
Generic Name: Lasalocid
Trade Name: DBOVATEC 68
Indications for Use: For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
Date of Approval: December 12, 2003

NADA 141-188 original approval
Sponsor: Bayer Animal Health
Generic Name: Ponazuril
Trade Name: Marquis™
Indications for Use: For the treatment of Equine Protozoal Myeloencephalitis (EPM) caused by Sarcocystis neurona
Date of Approval: July 19, 2001

NADA 141-189 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: Moxidectin
Trade Name: ProHeart® 6 Sustained Release Injectable for Dogs
Indications for Use: For the prevention of heartworm disease caused by Dirofilaria immitis and for treatment of existing larval and adult hookworm (Ancylostoma caninum) infections.
Date of Approval: June 06, 2001

NADA 141-189 supplemental approval
Sponsor: Fort Dodge Animal Health, Div. of American Home Products, Inc.
Generic Name: Moxidectin
Trade Name: ProHeart® 6 Sustained Release Injectable for Dogs
Effect of Supplement: New indication for the treatment of existing larval and adult hookworm (Uncinaria stenocephala) infections.
Date of Approval: June 13, 2002

NADA 141-189 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Moxidectin
Trade Name: PROHEART 6 Sustained Release Injectable for Dogs
Effect of Supplement: This supplement provides for the revision of the animal safety information in the warning, precaution, adverse reactions, and post-approval sections of the product labeling.
Date of Approval: May 23, 2008

NADA 141-190 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: Diclazuril, Bacitracin methylene disalicylate, Roxarsone
Trade Name: Clinacox plus BMD® plus 3-Nitro®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin or as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. For increased rate of weight gain, improved feed efficiency and improved pigmentation in broiler chickens.
Date of Approval: December 14, 2001

NADA 141-192 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Zeranol
Trade Name: Ralgro® LA
Indications for Use: For increased rate of weight gain for up to 210 days in pasture cattle (slaughter, stocker, and feeder steers and heifers).
Date of Approval: November 1, 2001

NADA 141-192 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Zeranol
Trade Name: Ralgro® L.A.
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: January 14, 2005

NADA 141-193 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: tepoxalin
Trade Name: ZUBRIN™ Rapidly-Disintegrating Tablets
Indications for Use: ZUBRIN™ (tepoxalin) Tablets are indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: March 31, 2003

NADA 141-194 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bacitracin methylene disalicylate
Trade Name: CLINACOX™, BMD®
Indications for Use: Growing Turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: April 2, 2002

NADA 141-195 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bambermycins
Trade Name: CLINACOX™, FLAVOMYCIN®
Indications for Use: Growing Turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for improved feed efficiency in growing turkeys or for the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: April 2, 2002

NADA 141-198 original approval
Sponsor: Elanco Animal Health, A division of Eli Lilly and Co.
Generic Name: Tylosin, salinomycin
Trade Name: Tylan® /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. brunette, and E. mivati in broiler chickens.
Date of Approval: September 4, 2002

NADA 141-199 original approval
Sponsor: Pfizer, Inc.
Generic Name: Carprofen
Trade Name: RIMADYL® INJECTABLE
Indications for Use: Rimadyl® Injectable is indicated for the relief of pain and inflammation associated with
osteoarthritis in dogs.
Date of Approval: March 3, 2003

NADA 141-199 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Carprofen
Trade Name: RIMADYL® INJECTABLE
Effect of Supplement: provides for the addition of a once daily administration of 2 mg/lb (4.4 mg/kg) of body weight in addition to a twice daily administration of 1 mg/lb (2.2 mg/kg) by subcutaneous injection.
Date of Approval: March 25, 2003

NADA 141-199 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Carprofen
Trade Name: RIMADYL® INJECTABLE
Effect of Supplement: This supplement to NADA 141-199 provides revisions to 21CFR 522.312 (2) Indications for Use. To add a claim for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.
Date of Approval: April 2, 2003

NADA 141-200 original approval
Sponsor: DEC INTERNATIONAL, INC
Generic Name: Intravaginal Progesterone Insert
Trade Name: EAZI-Breed™ CIDR® Cattle Insert
Indications for Use: 1. Synchronization of estrus in suckled beef cows, and replacement beef and dairy heifers. 2. Advancement of first postpartum estrus in suckled beef cows. 3. Advancement of first pubertal estrus in replacement beef heifers.
Date of Approval: May 2, 2002

NADA 141-200 supplemental approval
Sponsor: PHARMACIA & UPJOHN COMPANY
Generic Name: Progesterone
Trade Name: EAZI-Breed™ CIDR® Cattle Insert
Indications for Use: For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus
Date of Approval: July 29, 2003

NADA 141-200 supplemental approval
Sponsor: PHARMACIA & UPJOHN COMPANY
Generic Name: Progesterone
Trade Name: EAZI-Breed™ CIDR® Cattle Insert
Effect of Supplement: This supplement provides for the concurrent administration of progesterone solid matrix and dinoprost tromethamine for synchronization of estrus in lactating dairy cows.
Date of Approval: July 22, 2010

NADA 141-200 supplemental approval
Sponsor: Zoetis Inc.
Generic Name: Progesterone
Trade Name: EAZI-Breed™ CIDR® Cattle Insert
Effect of Supplement: This supplement provides for the addition of a new indication for induction of estrous cycles in anestrous lactating dairy cows.
Date of Approval: December 19, 2013

NADA 141-203 original approval
Sponsor: Novartis Animal Health US, Inc
Generic Name: deracoxib
Trade Name: DERAMAXX Chewable Tab
Indications for Use: DERAMAXX™ Chewable Tablets are indicated for the
control of postoperative pain and inflammation associated with orthopedic surgery in dogs > 4 lbs (1.8 kg).
Date of Approval: August 21, 2002

NADA 141-203 supplemental approval
Sponsor: Novartis Animal Health US, Inc
Generic Name: deracoxib
Trade Name: DERAMAXX Chewable Tab
Effect of Supplement: The supplement to NADA 141-203 provides revisions to 21 CFR 520.538. Indications for Use. To add a claim for the control of pain and inflammation associated with osteoarthritis in dogs. Amount: To add a new dose range of 1-2 mg/kg (0.45-0.91 mg/lb).
Date of Approval: February 11, 2003

NADA 141-203 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: deracoxib
Trade Name: DERAMAXX Tablets
Effect of Supplement: This supplement provides for the addition of a 75 mg tablet size.
Date of Approval: June 13, 2007

NADA 141-203 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Deracoxib
Trade Name: DERAMAXX Chewable Tablets
Effect of Supplement: This supplement provides for the addition of a 50-mg tablet size.
Date of Approval: May 16, 2008

NADA 141-203 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Deracoxib
Trade Name: DERAMAXX Chewable Tablets
Effect of Supplement: The supplemental NADA provides for the addition of a new indication for the control of postoperative pain and inflammation associated with dental surgery in dogs at a dose of 0.45-0.91 mg/lb (1-2 mg/kg) administered orally once daily for 3 days.
Date of Approval: November 23, 2011

NADA 141-204 original approval
Sponsor: Novartis Animal Health US
Generic Name: Milbemycin oxime/lufenuron, nitenpyram
Trade Name: Sentinel® Flavor Tabs® , Capstar® Tablets, Flea Management System™
Indications for Use: For use in dogs 4 weeks and older to kill adult fleas and to prevent flea eggs from hatching.
Date of Approval: June 11, 2003

NADA 141-205 original approval
Sponsor: Novartis Animal Health US
Generic Name: Lufenuron, nitenpyram
Trade Name: PROGRAM® Flavor Tabs® and CAPSTAR® Tablets
Indications for Use: For use to kill adult fleas and to prevent flea eggs from hatching.
Date of Approval: June 11, 2003

NADA 141-206 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: Florfenicol
Trade Name: Nuflor® 2.3% Concentrate Solution
Indications for Use: For treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
Date of Approval: September 4, 2002

NADA 141-207 original approval
Sponsor: Pfizer, Inc.
Generic Name: Danofloxacin mesylate
Trade Name: A 180®
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pastreurella) haemolytica and Pasteurella multocida.
Date of Approval: September 20, 2002

NADA 141-207 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Danofloxacin mesylate
Trade Name: Advocin™
Indications for Use: The supplemental NADA provides for an additional dosage regimen for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida in beef cattle at a single subcutaneous dose of 8 mg danofloxacin/kg body weight (BW).
Date of Approval: December 16, 2011

NADA 141-207 supplemental approval
Sponsor: Zoetis, Inc.
Generic Name: Danofloxacin
Trade Name: Advocin™ Sterile Injectable Solution
Indications for Use: This supplement provides for a new indication for the control of BRD in beef cattle at high risk of developing BRD associated with M. haemolytica and P. multocida.
Date of Approval: July 16, 2014

NADA 141-208 original approval
Sponsor: Bayer Corp.
Generic Name: Imidacloprid, invermectin
Trade Name: Advantage® DUO
Indications for Use: For the prevention of heartworm disease caused by Dirofilaria immitis. Also indicated for the treatment of flea infestation (Ctenocephalides felis).
Date of Approval: September 27, 2002

NADA 141-209 original approval
Sponsor: PHARMACIA & UPJOHN COMPANY
Generic Name: ceftiofur crystalline free acid
Trade Name: NAXCEL XT STERILE SUSPENSION
Indications for Use: NAXCEL XT STERILE SUSPENSION is indicated for treatment of BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida and H. omnus. NAXCEL XT STERILE SUSPENSION is also indicated for the control of respiratory disease in cattle which are at high risk of developing BRD associated with Mannheimia. haemolytica, P. multocida and H. somnus.
Date of Approval: September 5, 2003

NADA 141-209 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: EXCEDE Sterile Suspension
Effect of Supplement: 1. To add a new route of administration for injection in the posterior aspect of the ear where it attaches to the head (base of ear).
2. To add a new indication, “For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in lactating dairy cattle.”
3. To establish a 13-day pre-slaughter withdrawal period for cattle.
Date of Approval: June 2, 2006

NADA 141-209 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: EXCEDE Sterile Suspension
Effect of Supplement: This supplement provides for a new indication, treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.
Date of Approval: August 15, 2008

NADA 141-209 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: EXCEDE Sterile Suspension
Effect of Supplement: This supplement provides for a new indication, for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.
Date of Approval: December 16, 2009

NADA 141-209 supplemental approval
Sponsor: Pharmacia & Upjohn Co., a Division of Pfizer, Inc.
Generic Name: Ceftiofur crystalline free acid
Trade Name: Excede®
Effect of Supplement: This supplemental application provides for the addition of a new indication for the treatment of acute metritis (0 to 10 days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle; and to provide modified injection techniques for the base of the ear route of administration.
Date of Approval: February 21, 2012

NADA 141-210 original approval
Sponsor: RMS Laboratories, Inc.
Generic Name: Triamcinolone acetonide 0.015% topical spray
Trade Name: Genesis™ Topical Spray
Indications for Use: For the control of pruritus associated with allegic dermatitis in dogs.
Date of Approval: November 4 , 2002

NADA 141-211 original approval
Sponsor: Phibro Animal Health
Generic Name: Carbadox, oxytetracycline dihydrate base
Trade Name: Mecadox® 10 / Terramycin® 50, 100, or 200
Indications for Use: For the treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline, treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline, and increased rate of weight gain and improved feed efficiency.
Date of Approval: July 21, 2004

NADA 141-213 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: meloxicam
Trade Name: Metacam® Oral Suspension
Indications for Use: Metacam® Oral Suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: April 15, 2003

NADA 141-213 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: meloxicam
Trade Name: Metacam® Oral Suspension
Effect of Supplement: This supplement to NADA 141-213 provides revisions to 21 CFR 520.1350 (1) Amount. To change the format to read “administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, METACAM Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg).”
Date of Approval: October 28, 2004

NADA 141-214 original approval
Sponsor: Merial Limited
Generic Name: Ivermectin/praziquantel
Trade Name: Zimecterin® Gold Paste
Indications for Use: For treatment and control of the following parasites in horses: Tapeworms: noplocephala perfoliata Large strongyles (adults):
Strongylus vulgaris (also early forms in blood vessels) Strongylus edentatus (also tissue stages) Strongylus equinus Triodontophorus spp. including: Triodontophorus brevicauda Triodontophorus serratus
Craterostomum acuticaudatum Small strongyles: Including those resistant to some benzimidazole class compounds (adults and 4th stage larvae)
Coronocyclus spp. including: Coronocyclus coronatus Coronocyclus labiatus Coronocyclus labratus Cyathostomum spp. including:
Cyathostomum catinatum Cyathostomum pateratum Cylicocyclus spp. including: Cylicocyclus insigne Cylicocyclus leptostomum Cylicocyclus nassatus Cylicocyclus brevicapsulatus Cylicodontophorus spp.
Cylicostephanus spp. including: Cylicostephanus calicatus Cylicostephanus goldi Cylicostephanus longibursatus Cylicostephanus minutus Petrovinema poculatum Pinworms (adults and 4th stage larvae) - Oxyuris equi Ascarids (adults and 3rd and 4th 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 4th 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
Date of Approval: April 17, 2003

NADA 141-214 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin, praziquantel
Trade Name: Zimermectin® Gold Paste
Effect of Supplement: This supplement amends the ZIMECTRIN Gold (ivermectin/praziquantel) Paste labeling to reflect a change in the indications section. Specifically, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. The label language has also been revised for treatment frequency; removing the eight week intertreatment interval because treatment frequency should be based on a parasite control program designed specifically for each horse. A new precaution statement has also been added.
Date of Approval: July 13, 2004

NADA 141-214 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin/praziquantel
Trade Name: ZIMECTERIN Gold Paste
Effect of Supplement: This supplement amends the ZIMECTERIN Gold (ivermectin/praziquantel) Paste labeling to reflect the change in the age of treatment from “5 months of age and older” to “2 months of age and older.”
Date of Approval: October 28, 2005

NADA 141-215 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin/Pra ziquantel Paste
Trade Name: EQUIMAXTM Paste
Indications for Use: Indications: Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. EQUIMAX™ (ivermectin/praziquantel) Paste is indicated for the treatment and control of the following parasites:
Tapeworms: Anoplocephala perfoliata
Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp.
Small Strongyles including those resistant to some benzimidazole class compounds (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.
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.
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
Date of Approval: July 11, 2003

NADA 141-215 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin/praziquantel
Trade Name: EQUIMAX
Effect of Supplement: This supplement provides for the use of EQUIMAX Paste in breeding, pregnant or lactating mares without adverse effects on fertility.
Date of Approval: July 30, 2004

NADA 141-215 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: ivermectin/praziquantel
Trade Name: EQUIMAX
Effect of Supplement: This is a regulatory supplement requested by the Division of Surveillance to bring product labeling into compliance with the pioneer product. Therefore, this supplement provides for separation of small strongyle fourth-stage larvae from the small strongyle adults, which are speciated in the indication section of the product labeling. In addition, it revises the Warning statement to read “Do not use in horses intended for human consumption.”
Date of Approval: September 16, 2005

NADA 141-216 original approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Moxidectin, praziquantel
Trade Name: Quest® Plus Gel
Indications for Use: For the treatment and control of the following stages of gastrointestinal parasites of horses and ponies six months of age and older and not to be used for food
Date of Approval: May 14, 2003

NADA 141-216 original approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Moxidectin, praziquantel
Trade Name: Quest® Plus Gel
Indications for Use: For the treatment and control of the following stages of gastrointestinal parasites of horses and ponies
Date of Approval: March 17, 2004

NADA 141-216 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin and praziquantel
Trade Name: QUEST Plus Gel
Effect of Supplement: The supplement provides for the use of QUEST Plus gel for the treatment and control of adult Cylicocyclus radiatus and Petrovinema poculatus based on results from additional dose confirmation studies.
Date of Approval: November 23, 2005

NADA 141-217 original approval
Sponsor: Technology Transfer, Inc.
Generic Name: Zinc Gluconate Neutralized by Arginine
Trade Name: Neutersol® Injectable Solution
Indications for Use: Neutersol® Injectable Solution is indicated for chemical sterilization in 3 to 10 month old male dogs.
Date of Approval: March 17, 2003

NADA 141-218 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Cyclosporine capsules, USP Modified
Trade Name: ATOPICA
Indications for Use: For the control of atopic dermatitis in dogs weighing at least 4 lbs body weight.
Date of Approval: August 15, 2003

NADA 141-219 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Meloxicam
Trade Name: AMETACAM (meloxicam) 5 mg/mL Solution for Injection
Indications for Use: METACAM (meloxicam) 5 mg/mL Solution for Injection is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: November 12, 2003

NADA 141-219 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Meloxicam
Trade Name: METACAM 5 mg/mL Solution for Injection
Effect of Supplement: To add a claim 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: October 28, 2004

NADA 141-220 original approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: CYDECTIN Injectable Solution for Beef and Nonlactating Dairy Cattle
Indications for Use: CYDECTIN Injectable when administered at the recommended dose level of 0.2 mg/2.2 lb (0.2 mg/kg) body weight is effective in the treatment and control of the following internal and external parasites of cattle:
Date of Approval: May 20, 2005

NADA 141-220 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Moxidectin
Trade Name: CYDECTIN Injectable Solution for Beef and Nonlactating Dairy Cattle
Effect of Supplement: Addition of six new therapeutic claims:
Trichostrongylus colubriformis – Adult
Cooperia pectinata – Adult
Cooperia spatulata – Adult
Nematodirus helvetianus – Adult
Ostertagia ostertagi – L4
Trichostrongylus axei – L4
Date of Approval: January 10, 2006

NADA 141-221 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride
Trade Name: OPTAFLEXX™ 45
Indications for Use: 1) (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.
2) ( 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.
Date of Approval: June 13, 2003

NADA 141-221 supplemental approval
Sponsor:
Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride
Trade Name: OPTAFLEXX™ 45
Effect of Supplement: This supplement provides for top dress feeding of ractopamine hydrochloride 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: December 11, 2009

NADA 141-222 original approval
Sponsor: Intervet, Inc.
Generic Name: Altrenogest
Trade Name: MATRIX
Indications for Use: For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.
Date of Approval: September 30, 2003

NADA 141-223 original approval
Sponsor: Alpharma, Inc.
Generic Name: Diclazuril, roxarsone
Trade Name: Clinacox ™ / 3-Nitro®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunette, E. mitis (mivati), and E. maxima. Also, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
Date of Approval: January 27, 2004

NADA 141-224 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium, tylosin phosphate
Trade Name: Optaflexx ™ / Rumensin ® / Tylan ®
Indications for Use: 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 Actinomyces (Corynebacterium) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: January 27, 2004

NADA 141-224 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride, monensin USP, and tylosin phosphate
Trade Name: OPTAFLEXX plus RUMENSIN plus TYLAN
Effect of Supplement: This supplement provides for revised dosing for the combined use of ractopamine hydrochloride, monensin USP, and tylosin phosphate for cattle fed in confinement for slaughter, based on the December 1, 2006, supplemental approval for RUMENSIN (under NADA 095-735), which provided for an increase in the upper dosage limit in cattle being fed in confinement for slaughter. 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).
Date of Approval: October 12, 2007

NADA 141-224 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride, monensin USP, and tylosin phosphate
Trade Name: OPTAFLEXX plus RUMENSIN plus TYLAN
Effect of Supplement: This supplement provides for top dress application of ractopamine hydrochloride (OPTAFLEXX) Type C medicated feed administered on Type C medicated feeds containing monensin USP (RUMENSIN) and tylosin phosphate (TYLAN) 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: June 7, 2010

NADA 141-225 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium
Trade Name: Optaflexx ™ / Rumensin ®
Indications for Use: 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 for the last 28 to 42 days on feed.
Date of Approval: January 27, 2004

NADA 141-225 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride and monensin USP
Trade Name: OPTAFLEXX plus RUMENSIN
Effect of Supplement: This supplement provides for revised dosing for the combined use of ractopamine hydrochloride and monensin USP for cattle fed in confinement for slaughter, based on the December 1, 2006, supplemental approval for RUMENSIN (under NADA 095-735), which provided for an increase in the upper dosage limit in cattle being fed in confinement for slaughter.
Date of Approval: October 30, 2007

NADA 141-225 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride and monensin USP
Trade Name: OPTAFLEXX plus RUMENSIN
Effect of Supplement: This supplement provides for top dress application of ractopamine hydrochloride Type C medicated feed administered on Type C medicated feed containing monensin, USP 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.
Date of Approval: June 17, 2010

NADA 141-226 original approval
Sponsor: Phibro Animal Health
Generic Name: Semduramicin sodium Virginiamycin Roxarsone
Trade Name: AVIAX STAFAC ROXARSONE
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, E. mivati/E. mitis, for the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: April 6, 2005

NADA 141-227 original approval
Sponsor: Merial Ltd.
Generic Name: Omeprazole
Trade Name: UlcerGard ™
Indications for Use: For the prevention of gastric ulcers.
Date of Approval: February 18, 2004

NADA 141-228 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: N-butylscopolammonium bromide
Trade Name: Buscopan™ Injectable Solution
Indications for Use: BUSCOPAN Injectable Solution is indicated for the control of abdominal pain (colic) associated with spasmodic colic, flatulent colic, and simple impactions in horses.
Date of Approval: May 03, 2004

NADA 141-229 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Romifidine hydrochloride
Trade Name: Sedivet® 1% Injection
Indications for Use: For use as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedure, and minor surgical procedures. Also used as a preanesthetic prior to the induction of general anesthesia.
Date of Approval: June 3, 2004

NADA 141-230 original approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: Previcox™
Indications for Use: For the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: July 21, 2004

NADA 141-230 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: PREVICOX
Effect of Supplement: This supplement provides for the addition of a new indication for the control of postoperative pain and inflammation associated with soft-tissue surgery in dogs.
Date of Approval: December 18, 2007

NADA 141-230 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: PREVICOX
Effect of Supplement: This supplement provides for the addition of a new indication for the control of postoperative pain and inflammation associated with orthopedic surgery in dogs.
Date of Approval: September 23, 2008

NADA 141-232 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Cefpodoxime proxetil
Trade Name: Simplicef™
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, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.
Date of Approval: July 22, 2004

NADA 141-233 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium, tylosin phosphate, melengestrol acetate
Trade Name: Optaflexx™ / Rumensin® / Tylan® / 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 Actinomyces (Corynebacterium) 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: July 21, 2004

NADA 141-233 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride, monensin USP, tylosin phosphate and melengestrol acetate
Trade Name: OPTAFLEXX plus RUMENSIN plus TYLAN plus MGA
Effect of Supplement: This supplement provides for revised dosing for the combined use of ractopamine hydrochloride, monensin USP, tylosin phosphate and melengestrol acetate for heifers fed in confinement for slaughter, based on the December 1, 2006, supplemental approval for RUMENSIN (under NADA 095-735), which provided for an increase in the upper dosage limit in cattle being fed in confinement for slaughter. 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 increases the monensin tolerance in cattle liver from 0.05 to 0.10 ppm.
Date of Approval: September 11, 2007

NADA 141-234 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium, melengestrol acetate
Trade Name: Optaflexx™ / Rumensin® / 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: July 2, 2004

NADA 141-235 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: Excede™ For Swine
Indications for Use: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
Date of Approval: June 18, 2004

NADA 141-235 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: Excede™ For Swine
Effect of Supplement: This supplement provides for a new indication for the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.
Date of Approval: September 15, 2010

NADA 141-236 original approval
Sponsor: Intervet, Inc.
Generic Name: Porcine insulin zinc
Trade Name: Vetsulin™
Indications for Use: For the reduction of hyperglycemia and hyperglycemia associated clinical signs with diabetes mellitus.
Date of Approval: April 1, 2004

NADA 141-236 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Porcine insulin zinc suspension
Trade Name: VETSULIN
Effect of Supplement: This supplement provides for a new starting dose in dogs and for the use of VETSULIN in cats.
Date of Approval: March 24, 2008

NADA 141-236 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Porcine insulin zinc suspension
Trade Name: VETSULIN
Effect of Supplement: The effect of the supplement is to change the specification for non-extractable (NE) insulin.
Date of Approval: April 10, 2013

NADA 141-236 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Porcine insulin zinc suspension
Trade Name: VETSULIN
Effect of Supplement: The effect of the supplementis to add a 2.7 mL cartridge presentation for use with the VETPEN automatic injection device.
Date of Approval: February 3, 2014

NADA 141-238 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST LC Sterile Suspension
Indications for Use: SPECTRAMAST LC Sterile Suspension (ceftiofur hydrochloride) is indicated for the treatment of clinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. Cows with systemic clinical signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.
Date of Approval: February 9, 2005

NADA 141-238 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST LC Sterile Suspension
Effect of Supplement: To establish a 2-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 141-239 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST DC Sterile Suspension
Indications for Use: SPECTRAMAST DC Ceftiofur Hydrochloride Sterile Suspension is indicated for the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
Date of Approval: March 15, 2005

NADA 141-239 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST DC Sterile Suspension
Effect of Supplement: To establish a 16-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 141-240 original approval
Sponsor: Animal Health Pharmaceuticals, LLC
Generic Name: Sulfadiazine and pyrimethamine
Trade Name: REBALANCE Antiprotozoal Oral Suspension
Indications for Use: REBALANCE Antiprotozoal Oral Suspension is indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona
Date of Approval: November 5, 2004

NADA 141-241
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: Zimecterin-EZ™
Indications for Use: For 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, 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 16, 2004

NADA 141-244 original approval
Sponsor: Pfizer Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Indications for Use: Cattle: DRAXXIN Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni (Haemophilus somnus), and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni (Haemophilus somnus).
Swine: DRAXXIN Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, and Haemophilus parasuis.
Date of Approval: May 24, 2005

NADA 141-244
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: Draxxin®
Effect of Supplement: This application provides Mycoplasma bovis to the list of target pathogens for bovine respiratory disease (BRD) treatment indication. This approval qualifies for THREE years of marketing exclusivity.
Date of Approval: August 18, 2006

NADA 141-244 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Effect of Supplement: This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the BRD control “at high risk” indication.
Date of Approval: September 26, 2007

NADA 141-244 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Effect of Supplement: This supplement provides for 1) the addition of a new indication, for the treatment of IBK associated with Moraxella bovis in cattle, and 2) the addition of Mycoplasma hyopneumoniae to the list of pathogens for the SRD indication.
Date of Approval: December 28, 2007

NADA 141-244 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Effect of Supplement: This supplement provides for a new indication, for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef and non-lactating dairy cattle.
Date of Approval: August 28, 2008

NADA 141-244 supplemental approval
Sponsor:
Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name:  DRAXXIN Injectable Solution
Effect of Supplement: This supplement provides for a new indication, “for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.”
Date of Approval:
September 8, 2009

NADA 141-245 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: embutramide/chloroquine phosphate/lidocaine
Trade Name: TRIBUTAME* Euthanasia Solution
Indications for Use: TRIBUTAME Euthanasia Solution is indicated for euthanasia in dogs only. * During this product’s development, the proposed trade name was EMBUTANE. This trade name was changed to TRIBUTAME late in the development process. Therefore, most study titles refer to the product as EMBUTANE. However, the reader should be aware that the two trade names refer to the identical product and the word EMBUTANE has been changed to TRIBUTAME wherever possible.
Date of Approval: May 20, 2005

NADA 141-246 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: AQUAFLOR Type A Medicated Article (florfenicol), An Antibiotic
Indications for Use: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
Date of Approval: October 24, 2005

NADA 141-246 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: AQUAFLOR
Effect of Supplement: This supplement provides for the addition of the indication for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.
Date of Approval: March 19, 2007

NADA 141-246 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: AQUAFLOR
Effect of Supplement: This supplement provides for the addition of an indication for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida.
Date of Approval: October 26, 2007

NADA 141-246 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Florfenicol
Trade Name: AQUAFLOR
Effect of Supplement: This supplement provides for an increase in the maximum florfenicol dose for the existing enteric septicemia indication for catfish, the addition of new species/classes, and the addition
of indications for the control of mortality due to columnaris disease associated with Flavobacterium columnare in freshwater-reared finfish and for the control of mortality due to streptococcal septicemia associated with Streptococcus iniae in freshwater-reared warmwater finfish.
Date of Approval: April 4, 2012

NADA 141-246 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Florfenicol
Trade Name: AQUAFLOR
Effect of Supplement: This supplement provides an increase in the maximum daily dose for freshwater-reared finfish other than freshwater-reared warmwater finfish to provide a dosage range of 10-15 mg/kg body weight (BW)/day and to change the conditions of use to permit the use of florfenicol in recirculating aquaculture systems.
Date of Approval: January 29, 2014

NADA 141-247 original approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: CYDECTIN (moxidectin) Oral Drench for Sheep
Indications for Use: CYDECTIN Oral Drench for Sheep, when administered at the recommended dose of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight (BW), is effective in the treatment and control of the adult and larval (L4) stages of the following internal parasites of sheep:
Haemonchus contortus - Adult and L4 larvae
Teladorsagia circumcincta – Adult and L4 larvae
Teladorsagia trifurcata - Adult and L4 larvae
Trichostrongylus axei - Adult and L4 larvae
Trichostrongylus colubriformis - Adult and L4 larvae
Trichostrongylus vitrinus – Adult and L4 larvae
Cooperia curticei - Adult and L4 larvae
Cooperia oncophora – Adult and L4 larvae
Oesophagostomum columbianum - Adult and L4 larvae
Oesophagostomum venulosum – Adult and L4 larvae
Nematodirus battus - Adult and L4 larvae
Nematodirus filicollis - Adults and L4 larvae
Nematodirus spathiger - Adults and L4 larvae
Date of Approval: November 30, 2005

NADA 141-250 original approval
Sponsor: Alpharma Inc.
Generic Name: Chlortetracycline plus lasalocid sodium
Trade Name: 1) AUREOMYCIN 50, AUREOMYCIN 70, AUREOMYCIN 90 or AUREOMYCIN 100 plus 2) BOVATEC-68, BOVATEC-91, or BOVATEC-20 Liquid
Indications for Use: Indicated for the following numbered indications of combinations of chlortetracycline and lasalocid sodium: 1 and 5, 1 and 6, 1 and 7, 1 and 8, 2 and 7 (with the exception of dairy replacement heifers), 3 and 5, 3 and 6, 3 and 7 (with the exception of dairy replacement heifers), 3 and 8 (with the exception of dairy cattle), 4 and 5, 4 and 6, 4 and 7 (with the exception of dairy replacement heifers), 4 and 8 (with the exception of dairy cattle).
Chlortetracycline
1) 500 to 4,000 g/ton hand feed continuously for not more than 5 days to provide 10 mg/lb per day – for the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline in calves, beef, and non-lactating dairy cattle.
2) 0.5 mg/lb bodyweight daily – for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in beef cattle over 700 pounds.
3) 350 mg per head daily – for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in beef cattle under 700 pounds.
4) 350 mg per head daily – for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in beef cattle.
Lasalocid sodium
5) 10 to 30 g/ton to provide 100 to 360 mg lasalocid per head per day – for improved feed efficiency in cattle fed in confinement for slaughter.
6) 25 to 30 g/ton to provide 250 to 360 mg lasalocid per head per day – for improved feed efficiency and rate of weight gain in cattle fed in confinement for slaughter.
7) 30 to 600 g/ton to provide 60 to 300 mg/head/day in at least one pound of feed – for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers).
8) 30 to 181.8 g/ton to provide 1 mg/2.2 lb bodyweight per day – for the control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in cattle weighing up to 800 pounds with a maximum of 360 mg of lasalocid per head per day.
Date of Approval: March 31, 2006