Argatroban In Sodium Chloride (argatroban) PDUFA Date (Accord Hlthcare)
FDA PDUFA decision date for Argatroban In Sodium Chloride (argatroban) is July 31, 2026. Developed by Accord Hlthcare. Indication: Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC]. Current status: Approved.
Indication
Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC]
Regulatory details
- Company: Accord Hlthcare
- Application type: sNDA
- Review type: Standard
- PDUFA date: 2026-07-31
- Outcome: Approved