FDAsafety guidance83% confidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
Regulatory Analysis
Application ANDA075824. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Supporting Context
- Therapeutic area
- Gastroenterology · Crohn's Disease
- Sub-indication
- General
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