Requests that the FDA declare that an ANDA may be submitted for, Prazosin Hydrochloride Capsules, USP 3 mg and 4 mg, two strength’s that differ from the currently approved RLD, MINIPRESS (Prazosin Hydrochloride) capsules from PFIZER LABORATORIES DIV PFIZER INC., which FDA approved in 1 mg, 2 mg, and 5 mg strengths prior to Jan 1, 1982 under NDA #017442.
🏛 Food and Drug Administration (FDA)FDA-2026-P-5122
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