Treats thrombosis. ANDA 214235, held by Caplin. Argatroban.
As of Nov 15, 2026, ANDA 214235 (Argatroban), held by Caplin, was first approved by FDA on Jan 21, 2021, with 1 approved supplement 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 adult 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 21, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban50MG/50ML (1MG/ML) · injectable;injection | Argatroban | Rx |
| Jun 17, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 21, 2021 | Original application | 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
