FDAsafety guidance77% confidence
FDA AP — OXYCODONE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Metformin; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA200535. Sponsor: GENUS LIFESCIENCES. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: OXYCODONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Diabetes · Oral Hypoglycemic
- Sub-indication
- General
Related signal: FDA Grants Approval for Metformin Hydrochloride ANDA077060 by Zydus Lifesciences