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 Teva.
Regulatory Analysis
Application ANDA075435. Sponsor: TEVA PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: GABAPENTIN.
Supporting Context
- Therapeutic area
- Neurology · Anticonvulsant
- Sub-indication
- General
Related signal: Teva Pharmaceuticals Receives AP Status for Gabapentin Supplement