FDAsafety guidance72% confidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (rare disease) as Ipsen.
Regulatory Analysis
Application ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Supporting Context
- Therapeutic area
- Hepatology · Rare Disease
- Sub-indication
- Rare Disease
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