FDA Approves Sandoz Generic Trifluoperazine Hydrochloride Tablet (ANDA085785)

The U.S. Food and Drug Administration has granted approval for Abbreviated New Drug Application (ANDA) number ANDA085785. The application covers TRIFLUOPERAZINE HYDROCHLORIDE tablets marketed by Sandoz Inc. The product is an oral prescription drug, listed under both brand and generic name trifluoperazine hydrochloride, with a tablet dosage form and an equivalent strength of 1 mg base. Associated National Drug Codes (NDC) include 0781‑8028‑01, 0781‑8032‑01, 0781‑8034‑01, and 0781‑8036‑01. The submission record shows a series of supplemental applications (type "SUPPL") that received approval status ("AP"). These include manufacturing (CMC) approvals dated 1982‑12‑09, 1988‑01‑21, 1992‑03‑27, 1994‑01‑24, 1997‑08‑11, 1999‑06‑15, among others, as well as labeling approvals on 1989‑09‑15, 1993‑02‑26, and 1999‑03‑26. The approvals span a period from 1982 to 1999, indicating a comprehensive review of the product’s manufacturing and labeling information. This approval adds a generic version of trifluoperazine hydrochloride to the U.S. market, expanding prescribing options for healthcare providers and offering a potentially lower‑cost alternative for patients requiring this prescription medication.