requests the commissioner to make a determination that the drug product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA
🏛 Food and Drug Administration (FDA)FDA-2003-P-0282
Documents
3
Total comments
0
all analyzed
Comment status
Closed
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In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
OtherFeb 5, 2004
Letter from FDA CDER to International Regulatory Business Consultants, L.L.C.No comment period
- Other· Oct 10, 2003No comment period
- Other· Oct 10, 2003No comment period