Halothane: what the FDA reviewed for dog products

1 Freedom of Information summary from the FDA Center for Veterinary Medicine for products containing Halothane, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs, cats, and other non-food animals..

Products

Halothane, USP NADA 200-200, Original approval, April 10, 1997; sponsor Halocarbon Products Corp.; species: Dogs, cats, and other non-food animals.; foi_id 1428; FDA PDF

Indication

Induction and maintenance of general anesthesia in dogs, cats and other non-food animals.

Dose regimen

Induction: usually between 2% and 5% inhaled concentration, Inhalation, Continuous during anesthesia (vaporizer concentration adjusted to effect), Maintenance usually 0.5% to 2%; lower concentrations needed with oxygen/nitrous oxide, tranquilizer pre-medication or barbiturates

The concentration of Halothane, USP required to induce anesthesia will vary from patient to patient but will usually be between 2% and 5%.

Effectiveness

ANADA (generic of Fort Dodge Halothane, USP, NADA 14-170): bioequivalence established by chemical equivalence; in vivo bioequivalence waived; no effectiveness study conducted; result: Chemical equivalence accepted in lieu of in vivo bioequivalence testing

Bioequivalence of this generic animal drug, Halothane, USP, to the pioneer product, FORT DODGE LABORATORIES HALOTHANE, USP (Halothane, USP, NADA 14-170). was established by demonstration of chemical equivalence.

Extraction notes: Generic (ANADA) approval, 1997; no new studies. Species/Class recorded exactly as stated (dogs, cats and other non-food animals). Effectiveness field records the chemical-equivalence waiver only.

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