ARGATROBAN IN SODIUM CHLORIDE

FDA-2019-P-2687

AuroMedics Pharma LLC, the U.S. agent for Aurobindo Pharma Limited, filed this citizen petition on June 3, 2019, requesting that the FDA assign a therapeutic equivalence rating of AP to Aurobindo's Argatroban in Sodium Chloride Injection, 50 mg/50 mL, approved under 505(b)(2) NDA 209552, relative to

FDA-2015-P-2736

Comodo Health, Inc. filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that FDA determine the suitability of Argatroban in Sodium Chloride Injectable for intravenous use in three different vial fill sizes (25 mg/25 mL, 50 mg/50 mL, and 100 mg/100 mL) compared to the reference lis

FDA-2015-P-2736

Comodo Health Inc. filed a suitability petition regarding Sandoz's argatroban, a direct thrombin inhibitor used as an anticoagulant. The petition concerns the package insert and labeling for this generic injectable medication.

FDA-2009-P-0042

Mitsubishi Tanabe Pharma Corporation filed this citizen petition on January 30, 2009, requesting that the FDA require all ANDA and 505(b)(2) applications for argatroban to demonstrate compositional and clinical equivalence to the reference listed drug, including identical stereoisomer ratios, impuri