Treats thrombosis. ANDA 206698, held by Amneal Pharms Co. Argatroban.
As of Nov 15, 2026, ANDA 206698 (Argatroban), held by Amneal Pharms Co, was first approved by FDA on Jan 26, 2018, with 0 approved supplements and 0 published complete response letters.
Argatroban is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). 1.1 Heparin-Induced Thrombocytopenia Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban250MG/2.5ML (100MG/ML) · injectable;injection | Argatroban | Rx |
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
