FDAsafety guidance54% confidence
FDA AP — OXYCODONE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as ANI Pharmaceuticals.
Regulatory Analysis
Application ANDA209021. Sponsor: ASCENT PHARMS INC. Submission status: AP. Submission type: SUPPL. Active ingredients: OXYCODONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid Combination
- Sub-indication
- Pain
Related signal: ANI Pharmaceuticals submits supplemental application for Oxycodone and Aspirin