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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
Sulfadiazine, trimethoprim
200-244
Tucoprim® Powder
Sulfadiazine, trimethoprim

                                                                   
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Summary of 
FDA Information:

ANADA Approval Date:__Oct. 22, 1999 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA 200-244 TUCOPRIM Powder TUCOPRIM (sulfadiazine and
trimethoprim) is indicated for
the control of
bacterial infections of
horses during treatment of
acute strangles, respiratory tract infections, acute urogenital infections, wound infections, and

abscesses. Sponsored by: Pharmacia & Upjohn Co. 7000 Portage Road Kalamazoo, Michigan 49001.ANADA 200-244 Page 2 FREEDOM OF INFORMATION SUMMARY 1. General Information ANADA: 200-244 Sponsor: Pharmacia & Upjohn Co. 7000 Portage Road Kalamazoo, Michigan 49001 Trade Name: TUCOPRIM Powder Generic Name: trimethoprim/sulfadiazine powder Dosage Form: TUCOPRIM Powder is a formulation of
333 mg sulfadiazine and
67 mg trimethoprim per gram in a calcium carbonate (limestone) base. How Dispensed: Rx Route of
Administration: Orally in the
feed Species: Equine Indications for
Use: For control of
bacterial infections of
horses during treatment of
acute strangles, respiratory tract infections, acute urogenital infections, wound infections, and

abscesses. Labeled Dosage: The recommended dosage is 3.75 g TUCOPRIM Powder per 110 lbs (50 kg) body weight.
This provides 250 mg of
trimethoprim and
1250 mg of
sulfadiazine per 110 lbs body weight.
The product should be administered once daily in a small amount of
palatable feed for
five to seven days or
for two or
three days after clinical symptoms have subsided. Pioneer Product: UNIPRIM Powder, manufactured by Macleod Pharmaceuticals, Inc. (ANADA 200-033).ANADA 200-244 Page 3 2. Target Animal Safety and
Drug Effectiveness Under the provisions of
the Federal Food, Drug, and

Cosmetic Act, as amended by the Generic Animal Drug and
Patent Term Restoration Act (GADPTRA, 53 FR 50460, 15 December 1988, First GADPTRA Policy Letter), an abbreviated
new animal drug application (ANADA) may be submitted for
a generic version of
an approved new animal drug. New target animal safety, drug effectiveness data, and

human food safety data are not required.
The sponsor relies on the efficacy and
target animal safety of
the pioneer product, based on established bioequivalence between the two formulations. In this case, a waiver from
the requirement to conduct an in vivo bioequivalence study
(fifth GADPTRA Policy Letter: Bioequivalence Guideline, 12 April 1990) was
granted based on the chemical similarity of
the products.
The generic product contains the same active and
inactive ingredients, all in the
same concentration as the pioneer product.
The generic product is also the same dosage form, an oral powder, as the pioneer product. 3. Human Safety This product has the
following WARNING statements on the label, "Not for
human use. Keep out of
reach of
children. Not for
use in horses intended for
food". Human food safety data are not required. 4. Agency Conclusions This ANADA submitted under
section 512(b) of
the Federal Food, Drug, and

Cosmetic Act satisfies the requirements of
section 512(n) of
the Act and
demonstrates that when
Tucoprim Powder (sulfadiazine and
trimethoprim oral powder) is used under
the proposed conditions of
use, it is safe and
effective for
its labeled indications. Attachments: generic product labeling pioneer product labeling

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