FOI Documents NADA 000-000 to 139-999
Listed with Abstracts from the Summaries
NADA 006-707 supplemental approval
Sponsor: Solvay Animal Health, Inc.
Generic Name: sodium sulfaquinoxaline liquid
Trade Name: Sulquin 6-50 Concentrate
Effect of Supplement: DESI finalization recognizing that Sulquin 6-50 Concentrate is, when used as directed, safe and effective for the labeled indications.
Date of Approval: June 2, 1997
NADA 008-622 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: oxytetracycline Soluble Powder
Trade Name: Terramycin Soluble Powder
Effect of Supplement: One supplemental application is a Category II change to bring the drug product into compliance with the National Academy of Science/National Research Council Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations. The other supplemental application is a Category II change providing for a tolerance of O.1 ppm in uncooked edible tissues in sheep.
Date of Approval: July 9, 2000
NADA 008-622 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Terramycin®, Terramycin -343®
Effect of Supplement: This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days.
Date of Approval: April 25, 2001
NADA 008-622 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Oxytetracycline HCl
Trade Name: TERRAMYCIN-343 Soluble Powder
Effect of Supplement: To provide a new indication for the marking of skeletal tissues in finfish fry and fingerlings.
Date of Approval: June 13, 2005
NADA 008-804 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline Type A Medicated Article
Trade Name: Terramycin-10, 20, 50, 50D, 100, 100D, 100SS, & 200.
Effect of Supplement: This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days.
Date of Approval: March 14, 1996
NADA 008-804 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline Type A Medicated Article
Trade Name: TM-50®, TM-100®, TM-50®D, and TM-100®D
Effect of Supplement: This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days.
Date of Approval: April 29, 2002
NADA 008-804 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: sodium sulfaquinoxaline liquid
Trade Name: TM-50®, TM-50®D, TM-100®, TM-100®D Type A Medicated Articles
Indications for Use: For increased rate of weight gain and improved feed efficiency; reduction of liver abscesses; for prevention and treatment of the early stages of shipping fever complex; the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline.
Date of Approval: March 12, 2004
NADA 009-576 supplemental approval
Sponsor: Syntex Animal Health
Generic Name: estradiol benzoate and progesterone
Trade Name: Synovex® S
Effect of Supplement: This supplement provides for reimplantation of Synovex ; S at approximately day 70 in steers fed in confinement for slaughter for additional improvement in rate of weight gain.
Date of Approval: August 19, 1994
NADA 009-576 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: estradiol benzoate and progesterone
Trade Name: Synovex® C and Synovex® S
Effect of Supplement: This supplement provides for the implantation of Synovex C in steers fed in confinement for slaughter when used as part of a reimplant program where Synovex S is implanted at approximately day 70 after the initial implantation of Synovex C.
Date of Approval: July 14, 1998
NADA 009-576 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Progesterone and Estradiol Benzoate
Trade Name: SYNOVEX C and SYNOVEX S
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 010-005 supplemental approval
Sponsor: Fleming Laboratories, Inc.
Generic Name: Piperazine dihydrochloride, dipiperazine sulfate
Trade Name: Wazine® Pig Wormer
Effect of Supplement: This supplemental application provides for implantation in steers fed in confinement for slaughter for increased rate of weight gain and the establishment of an ADI for trenbolone.
Date of Approval: March 23, 1999
NADA 011-315 supplemental approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name: NEOMIX® 325 Soluble Powder and NEOMIX® AG 325 Soluble Powder
Effect of Supplement: The effectiveness neomycin sulfate was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: March 4, 1992
NADA 011-315 supplemental approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name: Neomycin 325/Neomix Ag 325 Soluble Powder
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats
Date of Approval: April 3, 1996
NADA 011-315 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: neomycin sulfate
Trade Name: NEOMIX® 325 Soluble Powder; NEOMIX® AG 325 Soluble Powder
Effect of Supplement: Provides for the use of neomycin sulfate (NEOMIX®325Soluble Powder/NEOMIX® AG 325 Soluble Powder/NEOMIX® AG 325 Soluable Powder) in growing turkeys for the control of mortality associted withEscherichia coli organisms sussceptible to neomycin sulfate.
Date of Approval: July 9, 1999
NADA 011-427 supplemental approval
Sponsor: Syntex, Inc.
Generic Name: Estradiol benzoate and testosterone propionate
Trade Name: Synovex-H Heifer Finishing Implants
Effect of Supplement: Supplemental application to provide for the deletion of the 60-day withdrawal period statement in the labeling for Synovex-H.
Date of Approval: July 9, 1999
NADA 011-427 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Testosterone Propionate and Estradiol Benzoate
Trade Name: SYNOVEX H
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 012-123 supplemental approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: erythromycin
Trade Name: GALLIMYCIN (Erythromycin)INJECTION, 200 mg/mL
Effect of Supplement: One supplemental application is a Category II change in dosage which was initiated in order to bring the drug product into compliance with the National Academy of Science/National Research Council- Drug. Efficacy Study Implementation (NAS/NRC/DESI) recommendations.The other supplemental application is a Category II change in tolerance for drug residues from zero to 0.1 ppm for beef tissues.
Date of Approval: June 30, 1993
NADA 012-350 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Amprolium
Trade Name: Corid® 25% Type A Medicated Article
Effect of Supplement: This application provides for formulation of Type C medicated calf feeds used for the prevention and treatment of coccidiosis at a broader range of concentrations (from 0.05% to 1.25% to 0.0125 to 1.25%).
Date of Approval: July 19, 2006
NADA 012-491 original approval
Sponsor: Elanco Animal Health, a Division of Eli Lily and Company
Generic Name: tylosin phosphate
Trade Name: TYLAN® 40 Type A medicated article TYLAN® 100 Type A medicated article TYLAN® 100 Cal Type A medicated article
Indications for Use: SWINE: For the prevention and/or control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; For increased rate of weight gain and improved feed efficiency; For prevention of swine dysentery (vibrionic); For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; and For the treatment and control of swine dysentery (vibrionic) following initial medication of TYLAN; in drinking water.
Date of Approval: November 8, 1996
NADA 012-491 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Tylosin phosphate
Trade Name: TYLAN 40, TYLAN 100, and TYLAN 100 Cal
Effect of Supplement: This supplement adds an alternative feeding regimen for the control of porcine proliferative enteropathies (PPE, ileitis) in swine: “feed 100 g tylosin per ton of complete feed for at least 3 weeks. Follow with 40 g tylosin per ton of complete feed until pigs reach market weight.”
Date of Approval: November 7, 2006
NADA 013-076 supplemental approval
Sponsor: Elanco Animal Health - A Division of Eli Lilly & Co.
Generic Name: Tylosin tartrate
Trade Name: TYLAN Soluble
Effect of Supplement: To add the indication for the control of American foulbrood (Paenibacillus larvae) in honey bees.
Date of Approval: October 17, 2005
NADA 034-025 supplemental approval
Sponsor: Pharmacia and Upjohn Company
Generic Name: Lincomycin hydrochloride
Trade Name: LINCOCIN® Sterile Solution; LINCOMIX® Injectable
Effect of Supplement: This supplement provides for the new tolerances for lincomycin in swine and the establishment of ADI for total residues of lincomycin.
Date of Approval: August 25, 1998
NADA 034-254 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA ® 100/200 Premix MGA ® 500 Liquid Premix
Effect of Supplement: This supplement provides for the removal of the requirement for a 48-hour drug withdrawal period prior to slaughter for heifers fed melengestrol acetate.
Date of Approval: June 29, 1994
NADA 034-254 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA® 100/200 Premix, MGA® 500 Liquid Premix
Effect of Supplement: This supplement provides for the use of melengestrol acetate (MGA) in heifers intended for breeding for suppression of estrus (heat).
Date of Approval: February 18, 1997
NADA 038-200 supplemental approval
Sponsor: Fermenta Animal Health Company
Generic Name: oxytetracycline hydrochloride
Trade Name: OXY WS (TM) Soluble Antibiotic; MEDAMYCIN ® Soluble Antibiotic
Effect of Supplement: The effectiveness oxytetracycline HCl soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: July 10, 1993
NADA 038-233 supplemental approval
Sponsor: Pitman-Moore, Inc.
Generic Name: zeranol
Trade Name: RALGRO ®
Effect of Supplement: This supplement provides for the deletion of the caution statement in the labeling against the use of RALGRO ; in heifer (suckling beef) calves intended for reproduction.
Date of Approval: March 30, 1994
NADA 038-233 supplemental approval
Sponsor: Schering-Plough Animal Health Corp
Generic Name: zeranol
Trade Name: RALGRO® Magnum
Effect of Supplement: This supplement provides for the use of an ear implant containing 72 mg zeranol in steers fed in confinement for slaughter for improved feed efficiency.
Date of Approval: June 25, 1999
NADA 038-233 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Zeranol
Trade Name: RALGRO RALGRO MAGNUM
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 038-233 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Zeranol
Trade Name: RALGRO
Effect of Supplement: This supplement provides for deletion of the no residue designation and regulatory method and addition of a tolerance for zeranol of 20 ppb in edible tissues of sheep published in 21 CFR 556.760.
Date of Approval: March 4, 2005
NADA 038-439 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline (from oxytetracycline dihydrate base) equivalent to oxytetracycline hydrochloride
Trade Name: TERRAMYCIN 200 for Fish
Effect of Supplement: This supplement provides for the change of the active ingredient from the mono-alkyl (C8-C18) trimethylammonium oxytetracycline to the oxytetracycline dihydrate, the change of the oxytetracycline concentration from 100 g/lb to 200 g/lb, the change of the product name to reflect the change in the oxytetracycline concentration, and the addition of the approved lobster indication to the label for the control of gaffkemia caused by Aerococcus viridans.
Date of Approval: June 30, 2006
NADA 039-077 supplemental approval
Sponsor: Fermenta Animal Health Company
Generic Name: chlortetracyline (as hydrochloride), sulfathiazole, penicillin (as procaine penicillin)
Trade Name: CSP(TM) 250 and CSP(TM) 500
Effect of Supplement: The supplemental NADA provides for revised Type A medicated article, and Type B and C medicated feed labeling. CSP(TM) can be used from 10 pounds body weight up to 6 weeks post-weaning.
Date of Approval: December 11, 1995
NADA 039-402 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA ® 100/200 Premix; MGA ® 500 Liquid Premix
Effect of Supplement: This supplement provides for the removal of the requirement for a 48-hour drug withdrawal period prior to slaughter for heifers fed melengestrol acetate.
Date of Approval: June 29, 1994
NADA 039-402 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate
Trade Name: MGA® 100/200 Premix, MGA® 500 Liquid Premix
Effect of Supplement: This supplement provides for the use of melengestrol acetate (MGA) in heifers intended for breeding for suppression of estrus (heat).
Date of Approval: February 18, 1997
NADA 039-417 supplemental approval
Sponsor: Rhone-Poulenc, Inc.
Generic Name: decoquinate, Type A medicated article.
Trade Name: Deccox®
Effect of Supplement: This supplement extends to non-ruminating calves the claim for the prevention of coccidiosis.
Date of Approval: April 12, 1991
NADA 039-417 supplemental approval
Sponsor: Rhone Poulenc Inc.
Generic Name: decoquinate
Trade Name: Deccox
Effect of Supplement: This supplement adds a new species (young sheep) to the approved label.
Date of Approval: August 18, 1995
NADA 039-417 supplemental approval
Sponsor: Rhone Poulenc Inc.
Generic Name: decoquinate
Trade Name: Deccox
Effect of Supplement: This supplemental application provides for a revised range of concentrations for the use of decoquinate in cattle, sheep and goats.
Date of Approval: September 4, 2002
NADA 040-209 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name: sulfadimethoxine and ormetoprim Type A medicated article
Trade Name: Rofenaid® 40
Effect of Supplement: This supplemental application provides for the addition of a new species (chukar partridges).
Date of Approval: April 1, 1999
NADA 041-061 supplemental approval
Sponsor: Pfizer Animal Health
Generic Name: Carbadox Type A Medicated Article
Trade Name: MECADOX ® 10
Effect of Supplement: Provides for the codificaiton of a revised tolerance for residues of carbadox in edible tissues.
Date of Approval: January 30, 1998
NADA 041-061 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Carbadox
Trade Name: Mecadox® 10 Type A Medicated Article
Effect of Supplement: Provides for the establishment of a 42 day slaughter withdrawal period for carbadox in swine tissues and a limitation against use in pregnant swine or swine intended for breeding purposes.
Date of Approval: October 5, 1998
NADA 042-841 supplemental approval
Sponsor: Fort Dodge Laboratories
Generic Name: kanamycin, pectin, bismuth subcarbonate, activated attapulgite (aluminum magnesium silicate)
Trade Name: Amforol® Veterinary Oral Tablets
Effect of Supplement: This supplement provides for a revised formulation for Amforol ; Veterinary Oral Tablets without aminopentamide hydrogen sulfate. The following issues are addressed:
Date of Approval: February 21, 1991
NADA 044-759 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Flavomycin ®
Effect of Supplement: 21 CFR 558.95 currently provides for the use of bambermycins in poultry and swine. This supplement provides for the use of bambermycins in cattle fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 21, 1993
NADA 046-592 supplemental approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate
Trade Name: BMD ®
Effect of Supplement: This supplement adds the claim for the control of clostridial enteritis caused by C. perfringens in suckling piglets born to sows medicated with BMD.
Date of Approval: April 29, 1991.
NADA 046-592 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD®
Effect of Supplement: This supplemental application provides for the addition of a class,replacement chickens, to be added to the previously approved product.
Date of Approval: June 22, 1998
NADA 046-666 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Procaine G Penicillin Premix
Trade Name: Procaine G Penicillin 50% Type A Medicated Article
Effect of Supplement: This supplemental application provides for compliance with theconclusions of the National Academy of Science/National Research Council(NAS/NRC) evaluation of penicillin-containing Type A Medicated Articles.
Date of Approval: April 10, 1998
NADA 046-668 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Procaine G Penicillin Premix
Trade Name: Procaine G Penicillin Type A Medicated Article
Effect of Supplement: This supplemental application provides for compliance with theconclusions of the National Academy of Science/National Research Council(NAS/NRC) evaluation of penicillin-containing Type A MedicatedArticles.
Date of Approval: April 10, 1998
NADA 046-699 supplemental approval
Sponsor: ALPHARMA, Inc.
Generic Name: Chlortetracycline
Trade Name: ChlorMax™ 50, ChlorMax™65, ChlorMax™70 Type A Medicated Article;
Effect of Supplement: This supplemental application adds the claim for the control of porcine proliferative enteropathies associated with Lawsonia intracellularis susceptible to chloretetracycline.
Date of Approval: July 7, 2000
NADA 046-718 (Liquid MGA) original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate (MGA)
Trade Name: MGA® 100/200 Premixes; MGA® 500 Liquid Premix
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduction of liver condemnation due to liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: May 6, 1998
NADA 046-719(Dry MGA) original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: melengestrol acetate (MGA)
Trade Name: MGA® 100/200 Premixes; MGA® 500 Liquid Premix
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduction of liver condemnation due to liver abscesses in heifers fed in confinement for slaughter.
Date of Approval: May 6, 1998
NADA 048-271 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Dichlorvos
Trade Name: Task® Tabs
Effect of Supplement: This supplemental application provides for the use in kittens not less than three months of age, for the use in adult dogs, and the addition of the 50 and 100 mg tablet sizes. Also, the list of sponsors is amended to reflect the sponsor’s current zip code (64506-2002).
Date of Approval: March 4, 1999
NADA 048-480 supplemental approval
Sponsor: A D M Animal Health & Nutrition, Inc.
Generic Name: Chlortetracycline Pre-mix
Trade Name: CHLORATET 50
Effect of Supplement: The effect of this Category II supplement is to bring the drug product into compliance with the National Academy of Science/National Research Council/ Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996
NADA 048-761 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: Chlortetracycline Pre-mix
Trade Name: Aureomycin Type A Medicated Article
Effect of Supplement: The approval provides for use of Aureomycin Type A Medicated Article for the control and treatment of specific diseases in swine, cattle, chickens,turkeys, and sheep.
Date of Approval: February 16, 1996
NADA 048-761 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: Chlortetracycline (CTC)
Trade Name: Aureomycin®
Effect of Supplement: This supplemental approval provides for a supplemental cattle feed (Moorman's Special Range Minerals AU Type C Medicated Feed) to provide 0.5-2.0 mg CTC/lb bodyweight/day for the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, in grazing beef cattle (weighing over 700 lbs). The resultant supplemental feed containing chlortetracycline is offered free-choice continuously throughout the period in which the cattle are grazing pasture.
Date of Approval: July 9, 1996
NADA 048-761 supplemental approval
Sponsor: Hoffmann La-Roche Inc.
Generic Name: chlortetracycline
Trade Name: Aureomycin®
Effect of Supplement: Changes all withdrawal times to zero (0) days when fed at certain doses.
Date of Approval: September 23, 1997
NADA 048-761 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name: Chlortetracycline Pre-mix
Trade Name: Aureomycin; Type A Medicated Article
Effect of Supplement: Deletion of limitations statement, "Do not feed to chickens producing eggs for human consumption" and establishment of a Tolerance for chlortetracycline in eggs.
Date of Approval: July 31, 1998
NADA 048-761 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name: Chlortetracycline
Trade Name: Aureomycin Type A Medicated Article
Effect of Supplement: Changes the withdrawal time from 24 hours to zero (0) day withdrawal when chlortetracycline is fed to chickens at 500 g/ton of feed for 5 days for reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline.
Date of Approval: October 26, 1998
NADA 048-761 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline
Trade Name: AUREOMYCIN® 50, 90 or 100 GRANULAR
Effect of Supplement: Provides for top dressing AUREOMYCIN at the rate of 10 mg chlortetracycline (equivalent to chlortetracycline hydrochloride) per pound of bodyweight of Type C medicated feeds for cattle.
Date of Approval: January 24, 2002
NADA 048-761 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline
Trade Name: AUREOMYCIN® 50, 90 or 100 GRANULAR
Effect of Supplement: This supplemental application adds the claim for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.
Date of Approval: November 15, 2001
NADA 048-761 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: Chlortetracycline
Trade Name: Aureomycin® 90 Granular
Effect of Supplement: This application provides for use of an approved Type A Medicated Article containing chlortetracycline to formulate a free-choice loose mineral Type C medicated feed (containing 6000 grams chlortetracycline per ton of feed) for beef and non-lactating dairy cattle. This approval qualifies for THREE years of marketing exclusivity.
Date of Approval: July 28, 2006
NADA 049-287 supplemental approval
Sponsor: Hoffmann-LaRoche Inc.
Generic Name: Pfichlor Chlortetracycline Pre-mix
Trade Name: Type A Medicated Article
Effect of Supplement: Category II change.
Date of Approval: July 7, 1993
NADA 055-020 supplemental approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline bisulfate soluble powder concentrate
Trade Name: Aureomycin Soluble Powder Concentrate
Effect of Supplement: This supplement upgrades the status finding of the NAS/NRC from "probably effective" to "effetive" with respect to the claims regarding control and treatment of the specifically noted diseases for certain animals as stated above.
Date of Approval: April 6, 1995
NADA 055-099 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: amoxicillin trihydrate/clavulanate potassium
Trade Name: Clavamox® Tabs
Effect of Supplement: Provides for additional claim against canine periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.
Date of Approval: December 23, 1997
NADA 055-101 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: amoxicillin trihydrate/clavulanate potassium
Trade Name: Clavamox® Drops
Effect of Supplement: Adds claims for periodontal infections in dogs.
Date of Approval: December 23, 1997
NADA 065-010 supplemental approval
Sponsor: Norbrook Laboratories Limited
Generic Name: Sterile Penicillin G Procaine Suspension USP
Trade Name: AQUA-CILLIN
Effect of Supplement: This supplement provides for the reduction of the milk withholding period from 72 hours (6 milkings) to 48 hours.
Date of Approval: July 16, 1992
NADA 065-071 supplemental approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline soluble powder
Trade Name: AUREOMYCIN Soluble Powder
Effect of Supplement: The effectiveness chlortetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: June 15, 1994
NADA 065-123 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: tetracycline soluble powder
Trade Name: TETRACYCLINE SOLUBLE POWDER
Effect of Supplement: The effectiveness tetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: February 18, 1994
NADA 065-140 supplemental approval
Sponsor: Wade Jones Company
Generic Name: tetracycline soluble powder
Trade Name: TET-SOL 324
Effect of Supplement: The effectiveness tetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: September 15, 1993
NADA 065-252 supplemental approval
Sponsor: Veterinary Services, Inc.
Generic Name: streptomycin sulfate 25% solution
Trade Name: Strep-SoL
Effect of Supplement: 1) The effectiveness streptomycin sulfate 25% solution was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary. 2) Change in tolerance
Date of Approval: September 5, 1993
NADA 065-256 supplemental approval
Sponsor: Feed Specialties Co.
Generic Name: chlortetracycline soluble powder
Trade Name: Chlortet-Soluble-O
Effect of Supplement: The effectiveness chlortetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: October 15, 1993
NADA 065-269 supplemental approval
Sponsor: American Cyanamid
Generic Name: tetracycline soluble powder
Trade Name: POLYOTIC
Effect of Supplement: The effectiveness tetracycline soluble powder was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: April 29, 1993
NADA 065-440 supplemental approval
Sponsor: American Cyanamid Company
Generic Name: chlortetracycline soluble powder concentrate
Trade Name: AUREOMYCIN Soluble Powder Concentrate
Effect of Supplement: The effectiveness chlortetracycline soluble powder concentrate was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: June 15, 1994
NADA 065-441 supplemental approval
Sponsor: American Cyanamid
Generic Name: tetracycline soluble powder concentrate
Trade Name: POLYOTIC
Effect of Supplement: The effectiveness tetracycline soluble powder concentrate was reviewed by the National Academy of Sciences/National Research Council Drug Efficacy Study Implementation (NAS/NRC DESI) and has been deemed effective when labeled as specified in the Indications and Recommended Dosage section of the summary.
Date of Approval: April 23, 1993
NADA 065-470 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD; Soluble
Effect of Supplement: This supplemental application provides for the addition of an additional species, growing quail, to the previously approved product.
Date of Approval: May 27, 1998
NADA 065-470 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate
Trade Name: BMD®Soluble
Effect of Supplement: This supplemental application provides for the addition of a new class, replacement chickens, to the previously approved product.
Date of Approval: February 2, 1999
NADA 065-480 supplemental approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline hydrochloride
Trade Name: Chlortetracycline Soluble Powder
Effect of Supplement: This supplemental application provides for a revised withdrawal period (from five to zero days) in swine.
Date of Approval: December 22, 1999
NADA 065-505 original approval
Sponsor: Anthony Products Co.
Generic Name: Penicillin G Procaine Suspension.
Trade Name: Microcillin-AG ®
Indications for Use: Microcillin-AG® ; in aqueous suspension is intended for use in the treatment of the following diseases when due to penicillin susceptible organisms in cattle, sheep, swine, and horses. Cattle and Sheep: Microcillin-AG ; is indicated for the treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida. Swine: Microcillin-AG ; is indicated for the treatment of erysipelas caused by Erysipelothrix insidiosa. Horses: Microcillin-AG ; is indicated for the treatment of strangles caused by Streptococcus equi.
Date of Approval: January 29, 1993
NADA 065-506 original approval
Sponsor: Anthony Products Co.
Generic Name: penicillin G benzathine and penicillin G procaine.
Trade Name: Combicillin ®; Combicillin-AG ®
Indications for Use: The prescription product, Combicillin ; is indicated for use in beef cattle, in horses, and in dogs for bacterial infections due to the following microorganisms that are susceptible to the serum levels of penicillin common to this particular dosage form: Pneumonia (shipping fever complex) caused by Streptococcus spp., Corynebacterium pyogenes, Staphylococcus aureus; Upper respiratory infections such as rhinitis or pharyngitis caused by Corynebacterium pyogenes; Equine strangles caused by Streptococcus equi; Blackleg caused by Clostridium chauvoei.
Date of Approval: November 8, 1993
NADA 065-506 supplemental approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Penicillin G Benzathine and Penicillin G Procaine
Trade Name: COMBICILLIN-AG (OTC label) trade name change
Effect of Supplement: This supplement provides for a change in the proprietary name on the OTC label product from COMBICILLIN-AG to COMBI-PEN-48 and the addition 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 of the product labeling.
Date of Approval: March 23, 2005
NADA 092-286 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Chlortetracycline Pre-mix
Trade Name: CLCT 10, 20, 30, 50, 70
Effect of Supplement: The effect of this Category II supplement is to bring the drug product into compliance with the National Academy of Science/National Research Council/ Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996
NADA 092-287 supplemental approval
Sponsor: Pfizer Inc
Generic Name: chlortetracycline pre-mix milk replacer
Trade Name: CLCT 50 MR & 100 MR
Effect of Supplement: The effect of this Category II supplement is to bring the drug product into compliance with the National Academy of Science/National Research Council/ Drug Efficacy Study Implementation (NAS/NRC/DESI) recommendations.
Date of Approval: February 16, 1996
NADA 092-444 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: morantel tartrate
Trade Name: Rumatel ® 88
Effect of Supplement: This supplement provides for an additional claim for use of this Type A medicated article to produce Type C medicated feed for Goats.
Date of Approval: March 17, 1994
NADA 094-170 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Phenylbutazone Tablets
Trade Name: Phenylbutazone Tablets USP 200 mg
Effect of Supplement: To provide for a 200 mg phenylbutazone tablet.
Date of Approval: January 12, 2001
NADA 095-143 original approval
Sponsor: Pfizer Inc.
Generic Name: oxytetracycline dyhydrate pre-mix
Trade Name: OXTC 10, 30, 50, 50-S, 100, 100-S, 100MR, 200
Indications for Use: For the control and treatment of specific diseases susceptible to oxytetracycline dihyrate pre-mix in swine, calves, cattle, chickens, turkeys, sheep, and honey bees.
Date of Approval: May 30, 1996
NADA 095-143 supplemental approval
Sponsor: Phibro Animal Health.
Generic Name: Oxytetracycline Type A Medicated Article
Trade Name: OXTC®-50, OXTC®-100, and OXTC®-200
Effect of Supplement: This supplement establishes a zero-day withdrawal period for swine administered oxytetracycline at 10 mg/lb/day for 14 days
Date of Approval: April 29, 2002
NADA 095-143 supplemental approval
Sponsor: Phibro Animal Health
Generic Name: Oxytetracycline
Trade Name: Terramycin® 50, Terramycin® 100, Terramycin® 200 Type A Medicated Articles
Indications for Use: For increased rate of weight gain and improved feed efficiency; reduction of liver abscesses; for prevention and treatment of the early stages of shipping fever complex; the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline.
Date of Approval: March 12, 2004
NADA 095-735 supplemental approval
Sponsor: Elanco Products Company
Generic Name: monensin (as monensin sodium)
Trade Name: Rumensin
Effect of Supplement: This supplement provides for an additional claim for the use of monensin in the prevention and control of coccidiosis in feedlot cattle.
Date of Approval: October 22, 1990
NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly & Co.
Generic Name: monensin sodium
Trade Name: Rumensin® 80 Type A Medicated Article
Effect of Supplement: This supplemental application provides for a revision of feeding directions, a weight-based dose for prevention and control of coccidiosis, and the establishment of an acceptable daily intake (ADI).
Date of Approval: December 16, 1998
NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly & Co.
Generic Name: monensin sodium
Trade Name: Rumensin® 80 Type A Medicated Article
Effect of Supplement: This supplemental application provides for the addition of a claim for the prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii.
Date of Approval: July 7, 2000
NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Monensin sodium
Trade Name: RUMENSIN 80
Effect of Supplement: The supplement to the NADA provides for addition of a new class of animals (dairy cows) and for the use of monensin in dairy cows to increase milk production efficiency (production of marketable solids-corrected milk per unit of feed intake).
Date of Approval: October 28, 2004
NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Monensin sodium
Trade Name: RUMENSIN 80
Effect of Supplement: This supplement provides for a change in the species class from pasture cattle (stocker and feeder cattle and dairy and beef replacement heifers) to growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers).
Date of Approval: November 18, 2005
NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Monensin sodium
Trade Name: RUMENSIN 80
Effect of Supplement: This supplement to the NADA provides for use of RUMENSIN 80 in dairy cows in component feeding systems (including top dress).
Date of Approval: December 15, 2005
NADA 095-735 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Monensin
Trade Name: RUMENSIN 80
Effect of Supplement: This supplement provides for an increase in the upper dose limit of monensin to 40 g/ton (480 mg/hd/day) in cattle being fed in confinement for slaughter for (1) improved feed efficiency and (2) prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii.
Date of Approval: December 1, 2006
NADA 096-298 original approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid
Trade Name: Bovatec®
Indications for Use: For increased rate of gain and for improved feed efficiency in beef cattle fed in confinement for slaughter.
Date of Approval: August 6, 1982
NADA 096-298 supplemental approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: lasalocid
Trade Name: Bovatec
Effect of Supplement: This supplement provides for use of a Roche formulation of a ruminant free-choice liquid Type C medicated feed for free-choice supplementation of pasture cattle.
Date of Approval: July 26, 1993
NADA 096-298 supplemental approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium
Trade Name: Avatec®
Effect of Supplement: This supplement provides for the use of Avatec® to prevent coccidiosis caused by Eimeria legionensis in chukar partridges.
Date of Approval: April 19, 1995
NADA 096-298 supplemental approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: lasalocid sodium
Trade Name: AVATEC
Effect of Supplement: Adds an additional claim for the prevention of coccidiosis in growing turkeys with a zero (0) day withdrawal time. The use level in feeds approved for broiler chickens at 68 to 113 grams per ton of feed (75-125 ppm) remains the same
Date of Approval: April 28, 1995
NADA 096-298 supplemental approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium
Trade Name: Avatec®
Effect of Supplement: This supplement adds an additional claim for the prevention of coccidiosis in young rabbits.
Date of Approval: October 20, 1995
NADA 096-298 supplemental approval
Sponsor: Roche Vitamins, Inc.
Generic Name: lasalocid sodium
Trade Name: Bovatec® Type A Medicated Article
Effect of Supplement: This supplement provides for the addition of a species and class (young rabbits) at a new lower concentration.
Date of Approval: February 5, 1999
NADA 096-298 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid
Trade Name: Avatec®
Effect of Supplement: This supplement provides for establishing tolerances for residues in chickens, turkeys and sheep liver and adding an acceptable daily intake (ADI).
Date of Approval: February 20, 2001
NADA 096-298 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid
Trade Name: Bovatec®
Effect of Supplement: This supplement, 21 CFR 558.311, currently provides for the use of lasalocid (1) to improve feed efficiency and increase rate of weight gain in cattle fed in confinement for slaughter, (2) to increase rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers) when fed daily in at least one pound of supplemental feed, and (3) to increase rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers) when lasalocid is provided in a free-choice supplemental feed. .
Date of Approval: July 25, 2001
NADA 096-298 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid
Trade Name: Bovatec®
Effect of Supplement: To provide for the use of lasalocid in a generic free-choice high-phosphorus loose mineral feed containing 1088 grams of lasalocid per ton feed.
Date of Approval: April 9, 2003
NADA 096-298 supplemental approval
Sponsor: Alpharma Inc
Generic Name: Lasalocid sodium
Trade Name: BOVATEC 68 BOVATEC 91 BOVATEC Liquid 20
Effect of Supplement: This supplement to the NADA provides for an alternate source of lasalocid, BOVATEC 91 Type A medicated article, in the free-choice cattle feeds codified in 21 CFR 558.311(e)(2), (3), and (4). They are the free-choice formulas containing 1440, 150 or 1088 g lasalocid/ton, respectively.
Date of Approval: October 20, 2006
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 110-315 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 111-798 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 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 126-050 supplemental approval
Sponsor: E
