FDAsafety guidance66% confidence
FDA AP — DULOXETINE HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Alembic; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA202949. Sponsor: ALEMBIC. Submission status: AP. Submission type: SUPPL. Review priority: UNKNOWN. Active ingredients: DULOXETINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Neurology · Depression
- Sub-indication
- General
Related signal: Alembic's Duloxetine Hydrochloride Supplement Receives AP Status from FDA
Source
FDA document
View source