Ampicillin Trihydrate: what the FDA reviewed for dog products

1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Ampicillin Trihydrate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs, cats, cattle, calves.

Products

Ampicillin Trihydrate NADA 200-180, Original approval, April 24, 1998; sponsor HQ Specialty Pharma Corp.; species: Dogs, cats, cattle, calves; foi_id 1421; FDA PDF

Indication

Respiratory tract, urinary tract, gastrointestinal, skin, soft-tissue and post-surgical infections in dogs and cats; respiratory tract infections in cattle and calves

Dose regimen

3 mg/lb body weight, Subcutaneous or intramuscular injection, Twice daily, Dogs and cats (cattle/calves: 2-5 mg/lb once daily IM)

Dogs and cats is 3 mg/lb. body weight twice daily by subcutaneous or IM injection.

Effectiveness

Generic (ANADA) approval; in vivo bioequivalence studies not required because active and inactive ingredients and manufacturing process are identical to the pioneer POLYFLEX® (NADA 55-030) (labelled as bioequivalence waiver, not an effectiveness study); result: Approved on the basis of identity with the pioneer 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.

Extraction notes: Generic ANADA (G.C. Hanford, 1998). Multi-species label (dogs, cats, cattle, calves); no PK, safety or field studies in the summary. Effectiveness field records the bioequivalence waiver.

Reproduce: foi_structured_search(query="Ampicillin Trihydrate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).