Requests that the FDA declare determine and declare that Promethazine Hydrochloride Tablets USP, 6.25 mg is suitable for submission in an Abbreviated New Drug Application (ANDA).
🏛 Food and Drug Administration (FDA)FDA-2026-P-8560
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Rules, notices, and supporting material — the primary rule pinned first.
- Supporting & Related Material· Aug 4, 2026