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U.S. Department of Health and Human Services

Animal & Veterinary

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096-301 to 137-600

NADA 097-452 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYJECT® 100
Effect of Supplement: This supplemental NADA provides for the subcutaneous route of administration and the application of new tolerances (61 FR 67435) to the approved product, Oxyject® 100  
Date of Approval: February 21, 1997

NADA 097-505 supplemental approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomycin Premixes
Effect of Supplement: This supplement provides for the following actions concerning use of Lincomycin in swine feed at the 40 and 20-gram-per-ton levels: (1) removal of the 6-day, preslaughter, drug withdrawal requirement; and (2) removal of the Lincomycin entry from the Category II table and addition of same to the Category I table in 21CFR 558.4.
Date of Approval: May 1, 1990

NADA 097-505 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix® 10/20/50 Feed Medications
Effect of Supplement: For treatment of swine dysentery. For treatment and control of swine dysentery. For reduction of severity of mycoplasmal pneumonia. For increase in rate of gain in growing-finishing swine. Broiler chickens--For increase of rate of weight gain and feed efficiency. For the control of necrotic enteritis.
Date of Approval: August 25, 1998

NADA 097-505 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: Lincomycin hydrochloride
Trade Name: Lincomycin® 20/50
Effect of Supplement: To add the label claim for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis.
Date of Approval: February 28, 2002

NADA 098-341 original approval
Sponsor: American Hoechst Corporation, Animal Health Division
Generic Name: bambermycins, roxarsone, monensin
Trade Name: Flavomycin®, 3-Nitro, Coban
Indications for Use: For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, E. brunetti; For increased rate of weight gain in broiler chickens
Date of Approval: March 4, 1985

NADA 100-094 original approval
Sponsor: Alpharma, Inc.
Generic Name: Sodium sulfamethazine, sodium sulfamerazine, and sodium sulfaquinoxaline
Trade Name: PoultrySulfa
Indications for Use: Acute Fowl cholera – TURKEYS AND CHICKENS: As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfamethazine, sulfamerazine and sulfaquinoxaline.
Coccidiosis – TURKEYS: As an aid in the control of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides susceptible to sulfamethazine, sulfamerazine, and sulfaquinoxaline.
Coccidiosis – CHICKENS: As an aid in the control of coccidiosis caused by Eimeria tenella and E. necatrix susceptible to sulfamethazine, sulfamerazine, and sulfaquinoxaline.
Date of Approval: February 2, 2006

NADA 100-901 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: chlortetracycline pre-mix
Trade Name: Pfichlor 100S Milk Replacer Type A Medicated Article
Effect of Supplement: Category II change
Date of Approval: January 27, 1998

NADA 100-929 original approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: sulfadimethoxine/ormetoprim
Trade Name: Primor Tablets
Indications for Use: Primor is to be used in the treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli susceptible to sulfadimethoxine/ormetoprim.
Date of Approval: November 24, 1989

NADA 100-929 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: sulfadimethoxine/ormetoprim
Trade Name: Primor® Tablets
Effect of Supplement: This supplemental Application amends the NADA to provide for the use of Primor; Tablets for the treatment of urinary tract infections caused by certaom bacteroa susceptible to sulfadimethoxine/ormetoprim. Primor® Tablets (NADA 100-929) is currently approved for use in dogs.
Date of Approval: August 5, 1996

NADA 101-331 original approval
Sponsor: Ralston Purina Co.
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Tablets
Indications for Use: For the removal of large roundworms (ascarids), Toxocara canis and Toxascaris leonina and hookworms, Anyclostoma caninum and Uncinaria stenocephala in dogs. The presence of these parasites should be confirmed by laboratory fecal examination. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
Date of Approval: November 14, 1978

NADA 101-331 supplemental approval
Sponsor: Ralston Purina Company
Generic Name: pyrantel pamoate
Trade Name: Dog Wormer Tablets
Effect of Supplement: Will provide for repeat treatment of puppies, lactating bitches and adult dogs for control of T. canis.
Date of Approval:

NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement provides for an additional species, cattle, to be added to the previously approved product, BANAMINE® Injectable Solution.
Date of Approval: May 5, 1998

NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement provides for an additional statement added to the Precaution section of the labeling and a heading change on the label from Warning to Adverse Reactions to the previously approved product labeling for BANAMINE® Injectable Solution.
Date of Approval: May 6, 1998

NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: Banamine® Injectable Solution
Effect of Supplement: This supplement allows for use in lactating dairy cattle for the existing indications of “the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia.” Additionally, it allows for a new indication “for the control of pyrexia associated with acute bovine mastitis” and it establishes a tolerance for residues of flunixin in milk.
Date of Approval: August 19, 2004

NADA 101-479 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Flunixin meglumine
Trade Name: BANAMINE-S (flunixin meglumine) Injectable
Effect of Supplement: This supplement allows for use in swine for the control of pyrexia associated with swine respiratory disease. This product has been approved for beef and lactating dairy cattle and horses.
Date of Approval: November 1, 2005

NADA 101-862 supplemental approval
Sponsor: Schering-Plough Animal Health
Generic Name: gentamicin sulfate veterinary
Trade Name: GARASOL® Injection
Effect of Supplement: This supplement provides for adding the previously approved turkey claims under NADA 47-486 to the labeling of NADA 101-862. The excipients in the formulations are identical, although the quantities are slightly different.
Date of Approval: March 28, 1996

NADA 104-646 original approval
Sponsor: Elanco Products Company
Generic Name: monensin sodium; Tylosin Phosphate
Trade Name: Rumensin®, Tylan®
Indications for Use: For improved feed efficiency and for reduction of incidence of liver abscesses in beef cattle caused by Sphaerophorus necrophorus and Corynebacterium pyogenes .
Date of Approval: March 6, 1976

NADA 104-646 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, tylosin phosphate
Trade Name: Rumensin®, Tylan®
Effect of Supplement: provides for the complete range of both individually approved drugs (Type A Medicated Articles) in Type B or C medicated feeds in combination for cattle fed in confinement for slaughter.
Date of Approval: November 19, 1998

NADA 104-646 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, tylosin phosphate
Trade Name: Rumensin®, Tylan®
Effect of Supplement: provides for the treatment of the approved combination of monensin plus tylosin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.
Date of Approval: February 2, 2001

NADA 106-964 original approval
Sponsor: Elanco Products Company
Generic Name: apramycin sulfate
Trade Name: APRALAN® Soluble Powder
Indications for Use: APRALAN® Soluble Powder (weanling pig scours) caused by strains of E. coli sensitive to apramycin.
Date of Approval: November 20, 1981

NADA 106-964 supplemental approval
Sponsor: Elanco Products Company
Generic Name: Apramycin Sulfate
Trade Name: APRALAN® Soluble Powder
Effect of Supplement: Control of porcine colibacillosis
Date of Approval: November 23, 1983

NADA 106-964 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: apramycin sulfate
Trade Name: APRALAN®
Effect of Supplement: Assigns an increased acceptable daily intake (ADI) and an increased safe concentration for total apramycin residues in edible tissues.
Date of Approval: June 24, 1997

NADA 106-965 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Trimethoprim/sulfadiazine
Trade Name: TRIBRISSEN 48% Injection
Effect of Supplement: The labeling supplement adds post-approval experience information, revises the warning statement, and updates the label format.
Date of Approval: April 26, 2006

NADA 107-996 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium, bacitracin methylene disalicylate
Trade Name: Avatec® plus BMD®
Effect of Supplement: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, an E, maxima, and for increased rate of weight gain and improved feed efficiency in broiler and fryer chickens.
Date of Approval: December 4, 2002

NADA 110-048 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: albendazole
Trade Name: Valbazen®
Indications for Use: Cattle anthelmintic for the removal and control of endoparasites infecting cattle.
Date of Approval: March 30, 1989

NADA 110-048 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Albendazole
Trade Name: Valbazen®
Effect of Supplement: Provides for the addition of a new species (sheep) at the more concentrated cattle formulation.
Date of Approval: December 02, 1998

NADA 110-048 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Albendazole
Trade Name: Valbazen®
Effect of Supplement: This supplement provides for the treatment of adult liver flukes (Fasciola hepatica) in non-lactating goats.
Date of Approval: January 24, 2008

NADA 110-315 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: progesterone plus estradiol benzoate
Trade Name: CALF-oid
Effect of Supplement: This supplement provides for the use of CALF-oid in suckling beef calves (at least 45 days of age) up to 400 lbs. of bodyweight.
Date of Approval: April 5, 1990

NADA 110-315 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: progesterone and estradiol benzoate
Trade Name: IMPLUS-C®
Effect of Supplement: This supplement provides for the deletion of the present labeling limitation against the use of Implus-C in heifer (suckling beef) calves intended for reproduction.
Date of Approval: January 22, 1997

NADA 110-315 original approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: progesterone, estradiol benzoate and and Tylosin Tartrate
Trade Name: Component® E-S with Tylan®
Indications for Use: Component® E-S with Tylan®: For increased rate of weight gain and improved feed efficiency in steers weighing 400 lbs or more.
Date of Approval: July 20, 1999

NADA 110-315 supplemental approval
Sponsor: Ivy Laboratories
Generic Name: Progesterone and Estradiol Benzoate, Progesterone and Estradiol Benzoate with Tylosin
Trade Name: COMPONENT E-C, COMPONENT E-S, COMPONENT E-C with TYLAN, and COMPONENT E-S with TYLAN
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 pre-ruminating 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: October 28, 2004

NADA 111-607 supplemental approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit® 5.68% Injectable Solution
Effect of Supplement: This Supplemental Application amends the NADA to provide for the use of Droncit Injectable Solution against Echinococcus multilocularis in dogs.
Date of Approval: July 16, 1993

NADA 111-636 supplemental approval
Sponsor: The Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix Soluble Powder
Effect of Supplement: This supplement provides for use of this product in broiler chickens. It also provides for the deletion of the tolerance for lincomycin residues in chickens.
Date of Approval: January 23, 1990

NADA 111-636 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix Soluble Powder
Effect of Supplement: This supplemental approval provides for the assignment of a tolerance of 0.6 ppm for lincomycin in swine liver, a tolerance of 0.1 ppm for lincomycin in swine muscle, and the assignment of an Acceptable Daily Intake (ADI) of 25 micrograms per kilograms per body weight per day for the total residues of lincomycin. In addition, this supplement reduces the slaughter period for drinking water uses of lincomycin in swine from 6 days to 0 days.
Date of Approval: August 25, 1998

NADA 111-636 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix Soluble Powder
Effect of Supplement: Provides for revision of the approved LINCOMIX Soluble Powder Insert Labeling replacing a caution for use only in swine weighing less than 250 pounds with a caution indicating safety has not been demonstrated for pregnant swine or swine intended for breeding.
Date of Approval: December 31, 2001

NADA 111-636 supplemental approval
Sponsor: Pharmacia & Upjohn Co., a Division of Pfizer, Inc.
Generic Name: lincomycin hydrochloride
Trade Name: Lincomix®
Effect of Supplement: This supplement application provides for the indication, “For the control of American foulbrood (Paenibacillus larvae) in honey bees.”
Date of Approval: March 27, 2012

NADA 111-798 supplemental approval
Sponsor: Mobay Corporation, Animal Health Division
Generic Name: praziquantel
Trade Name: CUTTER Tape-Tabs
Effect of Supplement: The purpose of the supplement is to provide for OTC marketing of praziquantel tablets for the indications listed below.
Date of Approval: January 18, 1990

NADA 111-798 supplemental approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit ® Feline Cestocide Tablets
Effect of Supplement: This supplement amends the NADA to provide for a 11.5 mg spherical tablet, which is half the concentration of the previously approved 23 mg tablet, for cats.
Date of Approval: January 11, 1993

NADA 111-798 supplemental approval
Sponsor: Miles, Inc.
Generic Name: praziquantel
Trade Name: Droncit® 34 mg Canine Tablets
Effect of Supplement: This Supplemental Application amends the NADA to provide for the use of Droncit Tablets against Echinococcus multilocularis in dogs. Droncit Tablets (NADA #111-798, 46 FR 60570 [December 11, 1981]) are currently approved for use in dogs and cats.
Date of Approval: July, 16, 1993

NADA 112-051 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Levamisole hydrochloride
Trade Name: Levasole ®
Effect of Supplement: Used for the following adult nematode infections:
Sheep:
Stomach Worms: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta.
Intestinal Worms: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina.
Lungworms:Dictyocaulus filaria.
Cattle:
Stomach Worms: Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei.
Intestinal Worms: Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum.
Lungworms:Dictyocaulus viviparus.
Date of Approval: December 23, 2003

NADA 113-232 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: LIQUAMYCIN® LA-200®
Effect of Supplement: This supplement provides for the codification of a revised tolerance for residues of oxytetracycline in edible tissues.
Date of Approval: March 28, 1996

NADA 113-232 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: LIQUAMYCIN® LA-200®
Effect of Supplement: This supplement provides for changes to the product labeling to include a subcutaneous (SC) route of administration in cattle. Also, the indications section of the labeling will be revised to include "pre-ruminating (veal) calves."
Date of Approval: April 23, 1997

NADA 113-232 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: oxytetracycline amphoteric
Trade Name: Liquamycin® LA-200
Effect of Supplement: This supplement provides for changes to the product labeling to include lactating dairy cows. Also, a tolerance for oxytetracycline in milk is established at 0.3ppm.
Date of Approval: July 21, 1998

NADA 115-581 supplemental approval
Sponsor: MoorMan's, Inc
Generic Name: Monensin Sodium
Trade Name: Rumensin®
Effect of Supplement: This supplement provides for the addition of the claim "for the prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii" to MoorMan's Type C monensin medicated free-choice protein-mineral blocks (MoorMan's Mintrate Blonde Block RU and MoorMan's Mintrate Red Block RU).
Date of Approval: September 27, 2001

NADA 116-088 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate, monensin, roxarsone
Trade Name: BMD®/Coban®/3-Nitro®
Effect of Supplement: This supplemental application adds the higher use level of bacitracin methylene disalicylate in broiler chicken feed (100 to 200 grams/ton) associated with the necrotic enteritis control claim which was approved under the single ingredient application (NADA 046-592).
Date of Approval: December 24, 1998

NADA 118-123 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Estradiol, oxytetracycline
Trade Name: COMPUDOSE ENCORE
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: October 28, 2004

NADA 118-980 supplemental approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin
Trade Name: Monteban®
Effect of Supplement: This supplement provides for the revision of 21 CFR 556.428 by the addition of tolerance for abdominal fat and acceptable daily intake (ADI).
Date of Approval: April 11, 2001

NADA 118-980 supplemental approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin
Trade Name: Monteban®
Effect of Supplement: This supplement application increases the upper limit of the dose range from 72 to 90 grams narasin per ton of feed for the prevention of coccidiosis in broiler chickens caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
Date of Approval: March 2, 2012

120-161 supplemental approval
Sponsor: Pharmacia & Upjohn Co
Generic Name: clindamycin hydrochloride
Trade Name: ANTIROBE Capsules
Effect of Supplement: The supplement provides for the use of clindamycin hydrochloride (ANTIROBE Capsules) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition, this supplement provides for the addition of a 300 mg capsule. This supplement also provides for the addition of recent MIC data derived from U.S. diagnostic laboratories.
Date of Approval: May 13, 2002

NADA 120-614 original approval
Sponsor: Webel Feeds, Inc.
Generic Name: Tylosin (as tylosin phosphate) combined with Sulfamethazine
Trade Name: Tylan 5, 10, 20, and 40 Sulfa-G.
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes)
Date of Approval: May 28, 1985

NADA 120-648 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: fenbendazole
Trade Name: Panacur ® and Safe-Guard®
Effect of Supplement: For treatment of encysted.mucosal cyathostome (small strongyle) larvae including hypobiotic early third stage, late third stage and fourth stage larvae at 10 mg/kg/day for 5 consecutive days.
Date of Approval: May 28, 1985

NADA 121-473 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Panacur® 22.2% Granules
Effect of Supplement: This supplement provides a claim as an anthelmintic in the following species within the families Felidae and Ursidae: lion (Panthera leo), tiger (Panthera tigris) cheetah (Acinonyx jubatus) Puma (Felis concolor), Jaguars (Panthera onca), Leopard (Panthera pardus), Panther (Panthera spp) Grizzly Bear (Ursus horribilis), Polar Bear (Ursus maritimus), and Black Bear (Ursus americanus).
Date of Approval: May 31, 1994

NADA 121-473 supplemental approval
Sponsor: Intervet Inc.
Generic Name: fenbendazole
Trade Name: PANACUR®-C
Effect of Supplement: This supplement provides for a change from prescription (Rx) to OTC status for fenbendazole granules 22.2% packets to be marketed under the trade name PANACUR®-C.  The jar presentation (Panacur®) will remain prescription (Rx) as it is also labeled for use in other species of carnivorous/omnivorous animals.  The jar presentation will continue to be marketed under the Panacur® trade name.
Date of Approval: March 19, 2002

NADA 122-578 supplemental approval
Sponsor: Anika Therapeutics, Inc.
Generic Name: Hyaluronate sodium
Trade Name: HYVISC® STERILE INJECTION
Effect of Supplement: To increase the concentration of hyaluronate sodium from 10 mg/mL to 11 mg/mL, and increase the dose from 20 mg to 22 mg for small joints and from 40 mg to 44 mg for large joints.
Date of Approval: September 30, 1998

NADA 124-309 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate and monensin sodium
Trade Name: MGA® 100/200 Premix; MGA® 500 Liquid Premix; RUMENSIN®
Effect of Supplement: This supplement provides for removal of the requirement for a preslaughter drug withdrawal period for heifers fed melengestrol acetate in combination with monensin. Previous approvals have required a 48-hour preslaughter drug withdrawal for melengestrol acetate.
Date of Approval: June 29, 1994

NADA 124-309 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin sodium
Trade Name: MGA® and Rumensin®
Effect of Supplement: 21 CFR 558.342(d)(2) currently provides for the combination use of melengestrol acetate and monensin to provide 0.25 to 0.4 mg/hd/day of melengestrol acetate and 50 to 360 mg/hd/day monensin for heifers being fed in confinement for slaughter for increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).These supplements provide for the treatment of the approved combination of melengestrol acetate and monensin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.  This effect is to provide for the addition of the claim for prevention and control of coccidiosis on a mg/lb body weight basis for monensin to this combination with melengestrol acetate for Type B and Type C medicated feeds for heifers being fed in confinement for slaughter.
Date of Approval: February 26, 2002

NADA 125-476 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate and monensin sodium
Trade Name: MGA® 100/200 Premix; MGA® 500 Liquid Premix; RUMENSIN®
Effect of Supplement: This supplement provides for removal of the requirement for a preslaughter drug withdrawal period for heifers fed melengestrol acetate in combination with monensin. Previous approvals have required a 48-hour preslaughter drug withdrawal for melengestrol acetate.
Date of Approval: June 29, 1994

NADA 125-476 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin sodium
Trade Name: MGA® and Rumensin®
Effect of Supplement: 21 CFR 558.342(d)(2) currently provides for the combination use of melengestrol acetate and monensin to provide 0.25 to 0.4 mg/hd/day of melengestrol acetate and 50 to 360 mg/hd/day monensin for heifers being fed in confinement for slaughter for increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).These supplements provide for the treatment of the approved combination of melengestrol acetate and monensin to be treated as a combination under the provisions of the Animal Drug Availability Act of 1996, and its reference to feed delivered drug combinations.  This effect is to provide for the addition of the claim for prevention and control of coccidiosis on a mg/lb body weight basis for monensin to this combination with melengestrol acetate for Type B and Type C medicated feeds for heifers being fed in confinement for slaughter.
Date of Approval: February 26, 2002

NADA 125-476 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: Melengestrol acetate and monensin
Trade Name: MGA plus Rumensin®
Effect of Supplement: This supplement provides for an increase in the upper dose limit of monensin to 480 mg/hd/day based upon the December 1, 2006, approval (NADA 095-735, C-0297) for monensin and an increase in the upper dose limit of melengestrol acetate to 0.5 mg/hd/day based upon the approval of melengestrol acetate (FR Vol. 42 No. 107 dated June 3, 1977), for increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in heifers fed in confinement for slaughter.
Date of Approval: October 1, 2009

NADA 126-050 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: apramycin sulfate
Trade Name: APRALAN® 75
Effect of Supplement: Increases acceptable daily intake and safe residue concentration levels in edible tissues.
Date of Approval: June 24, 1997

NADA 128-070 original approval
Sponsor: SmithKline Animal Health Products
Generic Name: Albendazole
Trade Name: VALBAZEN®
Indications for Use: Cattle anthelmintic for the removal and control of the following endoparasites and infecting cattle: A. Liver flukes:Fasciola hepatica (adults) B. Tapeworms:Moniezia benedeni, M. expansa (heads and segments) C. Lungworms:Dictyocaulus viviparus (adults and 4th stage larvae) D. Stomach worms: Barberpole worm: Haemonchus contortus, H. placei (adults and 4th stage larvae) Brown stomach worm: Ostertagia ostertagi (adults, 4th stage larvae and 4th stage inhibited larvae) Small stomach worm: Trichostrongylus axei (adults and 4th stage larvae) E. Intestinal worms: Hookworm: Bunostomum phlebotomum (adults) Threadnecked intestinal worm: Nematodirus spathiger, N. helvetianus (adults and 4th stage larvae) Small intestinal worm: Cooperia oncophora, C. punctata (adults and 4th stage larvae) Bankrupt worm: T. colubriformis (adults) Nodular worm: Oesophagostomum radiatum (adults)
Date of Approval: November 17, 1989

NADA 128-255 original approval
Sponsor: Kay Dee Feed Co.
Generic Name: tylosin, sulfamethazine
Trade Name: Tylan 5 Sulfa Premix, Tylan 10 Sulfa Premix
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: February 19, 1982

NADA 128-409 supplemental approval
Sponsor: MERCK & CO., INC.
Generic Name: Ivermectin
Trade Name: IVOMEC® Injection for Cattle
Effect of Supplement: This supplemental application is for the treatment and control of ear mites (Otodectes cynotis) in ranch-raised foxes.
Date of Approval: July 13, 1995

NADA 128-409 supplemental approval
Sponsor: MERCK & CO., INC.
Generic Name: Ivermectin
Trade Name: IVOMEC® Injection for Cattle
Effect of Supplement: New tolerance for residues of ivermectin B1a in cattle liver of 100 ppb and revised safe concentration in tissues
Date of Approval: September 13, 1995

NADA 128-409 supplemental approval
Sponsor: Merck & Co., Inc.
Generic Name: ivermectin
Trade Name: IVOMEC® Injection for Cattle and Swine
Effect of Supplement: New claims for persistent control of gastrointestinal roundworms and lungworms in cattle.
Date of Approval: February 24, 1997

NADA 128-409 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: IVOMEC® Injection for Cattle and Swine
Effect of Supplement: New claim for the treatment and control of grubs (Hypoderma bovis in American bison.
Date of Approval: December 19, 1997

NADA 128-409 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec® Injection for Cattle and Swine
Effect of Supplement: This supplemental application extends the period of persistent effect against infections of Dictyocaulus viviparus from 21 days to 28 days after treatment, and establishes an ADI in cattle muscle for total residues of ivermectin
Date of Approval: April 1, 1999

NADA 128-409 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: IVOMEC (ivermectin) Injection for Cattle and Swine
Effect of Supplement: To extend the persistent effect periods of Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information and to add the veal calf warning statement to the residue information section.
Date of Approval: August 16, 2004

NADA 128-620 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: PANACUR ®
Effect of Supplement: This supplement provides for an expanded use of fenbendazole in a new species (goats).
Date of Approval: April 25, 1994

NADA 128-620 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: Fenbendazole
Trade Name: Safe-Guard® Suspension 10%,Panacur® Suspension 10%
Effect of Supplement: This supplement provides for the use of fenbendazole for the removal and control of gastrointestinal parasites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996

NADA 128-620 supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: Fenbendazole
Trade Name: Panacur®, Safe-guard® Suspension 10%
Effect of Supplement: This supplement provides for establishing tolerances for residues of parent fenbendazole in muscle of cattle and goats.
Date of Approval: May 9, 2000

NADA 128-620 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Fenbendazole
Trade Name: Panacur®, Safe-guard® Suspension 10%
Effect of Supplement: 1) The marketing status of fenbendazole suspension for use in goats is changed from prescription (Rx) to over-the-counter (OTC) by removing goats from the PanacurÆÊ Suspension 10% label and by adding goats to the Safe-GuardR Suspension 10% label. The formulation of the two products is identical. 2) The indications for use in goats are revised from "for the removal and control of stomach and intestinal worms Haemonchus contortus and Ostertagia circumcincta" to "for the removal and control of stomach worms (adults) Haemonchus contortus and Teladorsagia circumcincta.¨
Date of Approval: February 13, 2003

NADA 128-686 supplemental approval
Sponsor: Agri-Bio Corporation
Generic Name: salinomycin sodium
Trade Name: Bio-Cox®
Date of Approval: September 1, 1994

NADA 128-686 supplemental approval
Sponsor: Hoffmann-La Roche
Generic Name: salinomycin sodium
Trade Name: Bio-Cox®
Effect of Supplement: To add roaster and replacement (breeder and layer) chickens to the label claim for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
Date of Approval: February 3, 1997

NADA 130-185 supplemental approval
Sponsor: Huvepharma AD
Generic Name: Amprolium and Bambermycins
Trade Name: AMPROL 25% and FLAVOMYCIN
Effect of Supplement: This supplement provides for the use of amprolium at 72.6 to 113.5 g per ton in combination with bambermycins at 1 to 2 g per ton in a Type C feed for prevention of coccidiosis caused by Eimeria tenella only, and for increased rate of weight gain and improved feed efficiency in broiler chickens. This supplement also provides for the use of amprolium at 113.5 to 227 g per ton in combination with bambermycins at 1 to 2 g per ton in a Type C feed for prevention of coccidiosis where immunity to coccidiosis is not desired and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: January 23, 2014

NADA 130-435 supplemental approval
Sponsor: I.D. Russell Company, Laboratories
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTET SOLUBLE
Effect of Supplement: This supplement provides for use of this product in swine.
Date of Approval: December 10, 1993

NADA 130-435 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Oxytetracycline HCl
Trade Name: Oxytet Soluble, Tetravet-CA
Effect of Supplement: This supplement provides for a revised withdrawal time of oxytetracycline hydrochloride soluble powder in the drinking water of turkeys and swine.
Date of Approval: November 29, 2000

NADA 130-435 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Oxytetracycline HCl
Trade Name: OxyMarine
Effect of Supplement: To add a claim for the marking of skeletal marking of tissues of all finfish fry and fingerlings.
Date of Approval: December 24, 2000

NADA 130-736 supplemental approval
Sponsor: Elanco Products Company
Generic Name: monensin
Trade Name: COBAN®
Effect of Supplement: This supplemental NADA (130-736) provides for a change in treatment regimen from a ten-week feeding period to a continuous feeding for growing turkeys.
Date of Approval: March 23, 1990

NADA 130-951 supplemental approval
Sponsor: Roussel Uclaf, Div. Agro-Veterinaire
Generic Name: halofuginone hydrobromide
Trade Name: Stenorol®
Effect of Supplement: Change of tolerance.
Date of Approval: March 8, 1991

NADA 130-951 supplemental approval
Sponsor: Roussel-Uclaf
Generic Name: halofuginone hydrobromide
Trade Name: STENOROL®
Effect of Supplement: This supplemental submission has been filed to provide for the same dose level of 2.72 g/t (3 ppm) to be fed to replacement cage laying chickens and replacement broiler breeder chickens for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. aacervulina, E. maxima, E. brunetti, and E. mivati / mitis.
Date of Approval: September 19, 1994

NADA 131-310 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: altrenogest
Trade Name: Regu-Mate® for Horses
Effect of Supplement: This supplement provides for label and package insert changes. This supplement does not affect the status of the original approval and Regu-Mate; (altrenogest) remains a "by prescription only" product.
Date of Approval: June 20, 1990

NADA 131-392 original approval
Sponsor: Merck Sharp and Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: IVOMEC® Liquid For Sheep
Indications for Use: For the control of certain gastrointestinal nematodes, lungworms, and nasal bots in sheep.
Date of Approval: July 26, 1988

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD® Type"A" Medicated Article (Premix)
Effect of Supplement: This supplement provides for an additional Type A medicated article (premix) containing 8% fenbendazole for the same indications for use in Type C medicated swine feed as the currently approved Type A medicated articles containing 4% and 20% fenbendazole. See 21 CFR 558.258.
Date of Approval: March 30, 1991

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard ®
Effect of Supplement: This supplemental approval provides for the minor use
claim as a dewormer in specific hoofed zoo and wildlife animals.
Date of Approval: November 20, 1990

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: fenbendazole
Trade Name: Safe-Guard® (fenbendazole)
Effect of Supplement: This supplement provides for the revision 21 CFR 556.275 by establishing tolerances for residues in swine liver and muscle and adding allowable daily intake (ADI).
Date of Approval: February 10, 2000

NADA 131-675 supplemental approval
Sponsor: Hoechst-Roussel Vet
Generic Name: fenbendazole
Trade Name: Safe-Guard®
Effect of Supplement: This supplement provides for the addition of growing turkeys to the previously approved SAFE-GUARD® Type A medicated article labeling.
Date of Approval: July 3, 2000

NADA 131-675 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: fenbendazole
Trade Name: Safe-Guard®
Effect of Supplement: This supplement to NADA 131-675 provides for a new claim for control of gastrointestinal worms in horses [large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (Oxyuris equi), and ascarids (Parascaris equorum)].
Date of Approval: March 14, 2003

NADA 131-675 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: fenbendazole
Trade Name: Safe-Guard®
Effect of Supplement: This supplement provides for the Type A medicated article to be used to manufacture a free-choice liquid Type C medicated feed for use in dairy and beef cattle.
Date of Approval: March 17, 2008

NADA 131-918 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: trimethoprim/sulfadiazine
Trade Name: TRIBRISSEN 400 Oral Paste
Effect of Supplement: This is a regulatory supplement requesting changes recommended by the Division of Surveillance and ONADE.  The labeling supplement adds post- approval experience information, revises the warning statement, and updates the label format.
Date of Approval: April 25, 2006

NADA 132-337 supplemental approval
Sponsor: Miles, Inc.
Generic Name: cythioate
Trade Name: Proban ® 90 mg tablets
Effect of Supplement: This supplement amends the NADA to provide for a 90 mg tablet and minor labeling changes. The currently approved tablet is 30 mg.
Date of Approval: April 25, 1994

NADA 132-872 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: fenbendazole
Trade Name: Safe-Guard® Paste 10%; Panacur® Paste 10%
Effect of Supplement: This supplement provides for the use of fenbendazole for the removal and control of gastrointestinal parasites and lungworm in dairy cattle of breeding age.
Date of Approval: March 28, 1996

NADA 133-953 supplemental approval
Sponsor: Mobay Corporation
Generic Name: Febantel and Praziquantel
Trade Name: Vercom Paste Anthelmintic
Effect of Supplement: This supplement provides for the addition of the following warning statement to the label: "Warning: Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction."
Date of Approval: September 12, 1991

NADA 134-314 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: EQVALAN® Paste 1.87%
Effect of Supplement: The supplement provides for the use of ivermectin paste for the treatment and control of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus spp. including: Coronocyclus coronatus, and Coronocyclus labratus. Also, the label descriptions of some currently-approved parasite genera are being revised to add included species for which data already exists in the NADA file and to reflect changes in scientific nomenclature.
Date of Approval: April 2, 2003

NADA 134-314 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: EQVALAN® Paste 1.87%
Effect of Supplement: This supplement amends the EQVALAN (ivermectin) Paste 1.87% 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.
Date of Approval: August 9, 2004

NADA 134-779 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: morantel tartrate
Trade Name: Paratect Flex(TM)
Effect of Supplement: This supplemental application provides an additional dosage form for the Morantel tartrate cartridge (Paratect Cartridge) which has been approved since 1984 under this same NADA.
Date of Approval: March 25, 1991

NADA 134-830 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin zinc, monensin sodium
Trade Name: Albac®, Coban®
Indications for Use: As an aid in prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima and E. mivati; for increased rate of weight gain, and for improved feed efficiency in broiler chickens.
Date of Approval: September 1, 1992

NADA 135-321 supplemental approval
Sponsor: Roche Vitamins & Fine Chemicals
Generic Name: salinomycin sodium, bacitracin methylene disalicylate, roxarsone
Trade Name: Bio-Cox®; BMD®; 3-Nitro®
Effect of Supplement: Category II supplemental change providing for an additional use level of roxarsone.
Date of Approval: May 5, 1997

NADA 135-906 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Testosterone Propionate, Estradiol Benzoate, and Tylosin Tartrate
Trade Name: Component® E-H with Tylan®
Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® E-H.
Date of Approval: July 20, 1999

NADA 135-906 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Testosterone Propionate and Estradiol Benzoate with Tylosin
Trade Name: COMPONENT E-H with TYLAN
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: October 18, 2004

NADA 135-940 supplemental approval
Sponsor: Pharmacia and Upjohn
Generic Name: clindamycin hydrochloride
Trade Name: ANTIROBE AQUADROPS Liquid
Effect of Supplement: The supplement provides for the use of clindamycin hydrochloride (ANTIROBE AQUADROPS Liquid) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition, this supplement provides for an expanded dose range of 5-15 mg/lb every 24 hours in cats. This supplement also provides for the addition of recent MIC data derived from a survey of U.S. diagnostic laboratories.
Date of Approval: May 13, 2002

NADA 135-940 supplemental approval
Sponsor: Pharmacia and Upjohn
Generic Name: Clindamycin hydrochloride oral liquid
Trade Name: ANTIROBE AQUADROPS
Effect of Supplement: This supplement provides for the use of clindamycin HCl (ANTIROBE AQUADROPS Liquid) in cats for new indications.
Date of Approval: October 7, 1996

NADA 135-940 supplemental approval
Sponsor: The Upjohn Co
Generic Name: Clindamycin hydrochloride oral liquid
Trade Name: Antirobe Aquadrops
Effect of Supplement: This supplemental application provides for the following additional claims: Aerobic bacteria: for the treatment of dental infections caused by susceptible strains of Staphylococcus aure us. Anaerobic bacteria: for the treatment of soft tissue infections (deep wounds and abscesses), dental infections, and osteomyelitis caused by or associated with susceptible strains of Bacteroides fragilis, Bacteroides melaninogenicus, Fusobacterium necrophorumand Clostridium perfringens.
Date of Approval: November 16, 1989

NADA 136-383 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: Polysulfated Glycosaminoglycan
Trade Name: Adequan
Indications for Use: Adequan is recommended for the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses.
Date of Approval: December 7, 1984

NADA 136-483 supplemental approval
Sponsor: Norden Laboratories
Generic Name: diethylcarbamazine citrate and oxibendazole chewable tablets
Trade Name: Filaribits® Plus Chewable Tablets
Effect of Supplement: Results in the addition of a label statement to provide for the removal and control of mature and immature stages of intestinal Toxocara canis (ascarid infection). Adequate data showing efficacy for the additional use has been submitted in the supplemental application which is the subject of this approval.
Date of Approval: January 18, 1989

NADA 136-742 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Clorsulon
Trade Name: Curatrem® Drench
Effect of Supplement: This supplement provides for the revision of 21 CFR 556.163 by the addition of tolerance in muscle of cattle and acceptable daily intake (ADI) and deletion of safe concentrations.
Date of Approval: May 16, 2001

NADA 137-537 original approval
Sponsor: A.H. Robins Company
Generic Name: salinomycin and lincomycin
Trade Name: Bio-Cox and Lincomix®
Effect of Supplement: Anticoccidial and Growth Promotant. Note: This application provides for the combined use of two currently approved Type A medicated articles in the manufacture of Type C medicated feeds for broiler chickens
Date of Approval: May 22, 1989

NADA 137-600 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole
Trade Name: SAFE-GUARD(TM)
Effect of Supplement: The original approval for this NADA provided for the use of Type A Medicated Article in complete feeds for cattle for the removal and control of the listed parasites. The Type "C" medicated complete feed was fed as a single dose of 5 mg fenbendazole per kilogram of body weight. This supplemental submission has been filed to provide for that same dosage of 5 mg/kg body weight to be fed free-choice in a vitamin/mineral supplement (Type C feed) administered over a three to six day period for the removal and control of the listed parasites
Date of Approval: August 30, 1989

NADA 137-600 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: fenbendazole
Trade Name: Safe-Guard® 20% Type A Medicated Article, Safe-Guard® 0.5% Cattle Top Dress, Safe-Guard® 35% Free Choice Mineral
Effect of Supplement: This supplement provides for the use of Safe-Guard® premixes for the removal and control of gastrointestinal parasites and lungworm in a new class, dairy cattle of breeding age.
Date of Approval: March 28, 1996