FDAsafety guidance72% confidence
FDA AP — OXYCODONE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Unique Pharmaceutical Laboratories.
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
- Allergy · Antihistamine
- Sub-indication
- General
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