FDAsafety guidance54% confidence
FDA AP — GABAPENTIN (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Sandoz.
Regulatory Analysis
Application ANDA203934. Sponsor: ZYDUS PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: GABAPENTIN.
Supporting Context
- Therapeutic area
- Neurology · Anticonvulsant
- Sub-indication
- General
Related signal: Sandoz's Gabapentin ANDA075428 Receives Abbreviated Approval