Mumbai, July 26 -- Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol-XR Extended Release Tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation.
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