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The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets, 400 mg, of Sanofi-Aventis U.S. LLC (Sanofi-Aventis).
NEW DELHI, Jan 10: Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market generic Dronedarone tablets, which is used to reduce risk of hospitalisation for atrial fibrillation, in the American market. The company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its medication in strength of 400 mg, the drug maker said in a statement. The tentatively approved ANDA is therapeutically […]