FDAsafety guidance66% confidence
FDA TA — ANDA220639
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Lupin Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA220639. Sponsor: ALEMBIC PHARMACEUTICALS LIMITED. Submission status: TA. Submission type: ORIG. Review priority: STANDARD.
Supporting Context
- Therapeutic area
- Infectious Disease · Antibiotic
- Sub-indication
- General
Related signal: Lupin's Doxycycline ANDA204234 Receives AP Status from FDA