FDAsafety guidance66% confidence
FDA AP — HYDROCODONE BITARTRATE AND IBUPROFEN (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Amneal Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA076642. Sponsor: AMNEAL PHARMS NY. Submission status: AP. Submission type: SUPPL. Active ingredients: HYDROCODONE BITARTRATE, IBUPROFEN.
Supporting Context
- Therapeutic area
- Pain Management · Opioid Combination
- Sub-indication
- Pain
Related signal: FDA Approval Update for Hydrocodone Bitartrate and Ibuprofen by Amneal Pharmaceuticals