Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg, and 120 mg strengths. The product is the generic equivalent of Bausch Health’s Cardizem tablets and is indicated for the management of chronic stable angina and angina caused by coronary artery spasm.
With this approval, the company now holds a cumulative total of 230 ANDA approvals from the USFDA, comprising 210 final and 20 tentative approvals.
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