ARGATROBAN IN SODIUM CHLORIDE

FDA-2022-P-2498

Eugia US LLC, the U.S. agent for Eugia Pharma Specialities Limited, filed this petition requesting that the FDA assign a therapeutic equivalence rating of 'AP' to Eugia's Argatroban in Sodium Chloride Injection, 50 mg/50 mL, approved under 505(b)(2) NDA 209552, when compared to the reference listed

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 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-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-2014-P-0813

Lachman Consultant Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Argatroban Injection, 1 mg/mL in a 50 mg/50 mL strength suitable for submission in an ANDA, based on the Sandoz listed drug Argatr