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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
Pharmaceutical Policy
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📄 Primary document
OtherOct 5, 2004
Petition Approval from FDA CDER to Lachman Consultant Services, Inc.
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