Approval Date: April 24, 1998
I. GENERAL INFORMATION
G.C. Hanford Mfg. Co.
304 Oneida St.
Syracuse, NY 13201
A. Established Name: Ampicillin Trihydrate
B. Trade/Proprietary Name: Ampicillin Trihydrate
C. Dosage Form: Sterile powder for suspension
D. How Supplied:
- 10g/100mL vial
- 25g/250mL vial
E. How Dispensed: Prescription
F. Amount of Active Ingredients:
- 10g of ampicillin activity per 100mL vial
- 25g of ampicillin activity per 250mL vial
G. Route of Administration: Subcutaneous or Intramuscular Injection
H. Species: Dogs, cats, cattle, calves
I. Labeled Dosage:
Recommended dose for:
- Dogs and cats is 3 mg/lb. body weight twice daily by subcutaneous or IM injection.
- Cattle and calves including non-ruminating (veal calves) is 2-5 mg/lb. body weight once daily by IM injection.
J. Pharmacological Category: Antibiotic
K. Indications for Use: For the treatment of respiratory tract, urinary tract, gastrointestinal infections and skin, soft-tissue and post-surgical infection in dogs and cats. Respiratory tract infections in cattle and calves including non-ruminating (veal calves).
L. Pioneer/NADA #:
- Fort Dodge Animal Health
- POLYFLEX® (NADA 55-030)
II. TARGET ANIMAL SAFETY AND EFFECTIVENESS
In accordance with the provisions of the Federal Food, Drug and Cosmetic Act, as amended by the Generic Animal Drug and Patent Restoration Act and the Center’s first policy letter (53 FR 50460, December 15, 1988) and the Center’s fifth policy letter (June 18, 1990, 55 FR 24645), G. C. Hanford Mfg. Co. is entitled to the approval of the generic Ampicillin Trihydrate Suspension injectable product. In vivo bioequivalence studies were not required for the approval of this generic ampicillin trihydrate because both active and inactive ingredients, and the entire manufacturing process are identical to methods of the pioneer.
III. HUMAN FOOD SAFETY
The tolerances established for the pioneer product apply to the generic product. A tolerance of 0.01ppm is established for negligible residues of ampicillin in the uncooked edible tissues of cattle and in milk (21 CFR 556.40).
When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal times are those previously assigned to the pioneer product. The withdrawal times for ampicillin trihydrate for sterile suspension are established under 21 CFR 522.90b: 6 days for the edible tissues of cattle and 48 hours for milk.
Regulatory Method for Residues
The regulatory analytical method for detection of residues of the drug is a microbiological test using Staphylococcus epidermidis published by the Food and Drug Administration, "Antibiotic Residues in Milk, Dairy Products and Animal Tissues: Methods, Reports, and Protocols", revised October 1968, reprinted December, 1974.
IV. 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 Ampicillin Trihydrate sterile powder for suspension when used under its proposed conditions of use, is safe and effective for the labeled indications.
- Facsimile package label for generic ampicillin trihydrate sterile powder 10g/100mL vial and 25g/250mL vial.
- Approved pioneer package labels for Ampicillin Trihydrate® for 10g of ampicillin activity per 100mL: vial and 25g of ampicillin activity per 250mL: vial packages.