CORDARONE

FDA-2000-P-1558

Gensia Sicor Pharmaceuticals, Inc. filed an ANDA suitability petition requesting FDA approval for Camiodarone Hydrochloride Injection in a 900 mg/18 mL single-use vial strength. The petitioner argued that this new package size, designed to simplify preparation of the 1.8 mg/mL infusion concentration

FDA-2002-P-0397

Bioniche Pharma (Canada) Ltd. filed a supplemental ANDA suitability petition under 21 CFR 314.93 requesting permission to file a supplemental ANDA for Amiodarone Hydrochloride Injection, 50 mg/mL in a 9 mL vial (450 mg total content) based on approved ANDA 76-217, differing from the reference listed

FDA-2002-P-0444

Gensia Sicor Pharmaceuticals filed this suitability petition under Section 505(j)(2)(c) and 21 CFR 314.93 requesting permission to submit an ANDA for Amiodarone Hydrochloride Injection 450 mg/9 mL in a single-use vial. The petitioner seeks to change the strength from the reference listed drug Cordar

FDA-2000-P-1558

Gensia Sicor Pharmaceuticals filed a supplement letter to clarify the product nomenclature in their ANDA Suitability Petition for Camiolarone Hydrochloride Injection (Docket No. 00P-1352/CP1), explaining that they used the proposed USP nomenclature revision rather than the previous designation of Am

FDA-2002-P-0440

Lachman Consultant Services, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that an Abbreviated New Drug Application may be submitted for Amiodarone Hydrochloride Injection in strengths of 300 mg/6 mL and 450 m