Treats thrombosis. NDA 209552, held by Eugia Pharma Speclts. Argatroban.
As of Nov 13, 2026, NDA 209552 (Argatroban In Sodium Chloride), held by Eugia Pharma Speclts, was first approved by FDA on Nov 27, 2018, with 1 approved supplement and 0 published complete response letters.
Argatroban in sodium chloride injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) 1.1 Heparin-Induced Thrombocytopenia Argatroban in sodium chloride injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban In Sodium Chloride50MG/50ML (1MG/ML) · solution;intravenous | Argatroban | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Nov 27, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
