FDAsafety guidance83% confidence
FDA TA — ANDA220639
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Alembic Pharmaceuticals.
Regulatory Analysis
Application ANDA220639. Sponsor: ALEMBIC PHARMACEUTICALS LIMITED. Submission status: TA. Submission type: ORIG. Review priority: STANDARD.
Supporting Context
- Therapeutic area
- Not specified
- Sub-indication
- General
Related signal: Alembic Pharmaceuticals Submits ANDA220639 for Review