make a determination that a Hydrocodone Bitartrate and Acetaminophen tablet,USP 7.5 mg/300 300 mg combination drug product is suitable for submission as an ANDA this petition requestes a change in the strength of one of the active ingredients (acetaminophen) from 325 mg to 300 mg per tablet-CLOSED
🏛 Food and Drug Administration (FDA)FDA-2003-P-0280
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Rules, notices, and supporting material — the primary rule pinned first.
- Other· Oct 5, 2004No comment period
- Other· Sep 4, 2003No comment period