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As of Nov 15, 2026, ANDA 205570 (Argatroban In Sodium Chloride), held by Gland, was first approved by FDA on May 22, 2017, with 0 approved supplements and 0 published complete response letters.
First approved: May 22, 2017
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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.
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
