FDAsafety guidance66% 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 Rhodes Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA077712. Sponsor: STRIDES PHARMA INTL. Submission status: AP. Submission type: SUPPL. Active ingredients: OXYCODONE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: FDA Approves Oxycodone Hydrochloride Supplement by Rhodes Pharmaceuticals