FDAsafety guidance66% confidence
FDA AP — MORPHINE SULFATE (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 ANDA074862. Sponsor: RHODES PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: MORPHINE SULFATE.
Supporting Context
- Therapeutic area
- Pain Management · Opioid
- Sub-indication
- Pain
Related signal: FDA Accepts Supplemental NDA for Dilaudid by Rhodes Pharmaceuticals