FDAsafety guidance65% confidence
FDA AP — ARGATROBAN IN 0.9% SODIUM CHLORIDE (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 NDA206769. Sponsor: TEVA PHARMS USA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ARGATROBAN.
Supporting Context
- Therapeutic area
- Neurology · Anticonvulsant
- Sub-indication
- General
Related signal: Teva Pharmaceuticals Receives AP Status for Gabapentin Supplement