Treats thrombosis. NDA 22485, held by Plano Pharms. Argatroban.
As of Nov 14, 2026, NDA 22485 (Argatroban In Sodium Chloride), held by Plano Pharms, was first approved by FDA on May 9, 2011, with 6 approved supplements and 0 published complete response letters.
1 Argatroban in 0.9% 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 0.9% Sodium Chloride Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). 1.2 Percutaneous Coronary Intervention Argatroban in 0.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2011 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban In Sodium Chloride125MG/125ML (1MG/ML) · injectable;intravenous | Argatroban | RxReference drug |
| Sep 25, 2026 | Supplement 15Labeling · Standard review | Approved | |
| Apr 29, 2019 | Supplement 13Labeling · Standard review | Approved | |
| Jul 3, 2018 | Supplement 11Labeling · Standard review | Approved | |
| May 26, 2016 | Supplement 9Labeling · Standard review | Approved | |
| Dec 1, 2015 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 11, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 9, 2011 | 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
