USFDA Final Approval for Diltiazem Hydrochloride Tablets - Alembic Pharmaceuticals Ltd

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Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application Diltiazem Hydrochloride Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cardizem Tablets, 30 mg, 60 mg, 90 mg, and 120 mg, of Bausch Health US, LLC. Diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. Refer label for a detailed indication. Alembic has a cumulative total of 230 ANDA approvals (210 final approvals and 20 tentative approvals) from USFDA.