Alembic Pharmaceuticals has received US Food & Drug Administration (USFDA) Final Approval for Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Norpramin Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, of Validus Pharmaceuticals LLC. Desipramine Hydrochloride Tablets, USP are indicated for the treatment of depression.
Alembic has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA.
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