Alembic Pharmaceuticals receives USFDA Tentative Approval for Dronedarone Tablets USP, 400 mg. Kumar Jeetendra | January 10, 2022 10th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dronedarone Tablets USP, 400 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets, 400 mg, …
