Mumbai, April 17 -- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Tablets USP, 200 mg, are indicated for use as an anticonvulsant drug.
They are also indicated for the treatment of pain associated with true trigeminal neuralgia. Refer to the product label for the complete list of indications.
Carbamazepine Tablets USP, 200 mg, have an estimated market size of US$ 32 million for the twelve months ending December 2024, according to IQVIA.
With this approval, Alembic now has a cumulative total of 222 ANDA approvals from the USFDA, comprising 196 final approvals and 26 tentative approvals.
Alembic Pharmaceuticals ...
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