Alembic Pharmaceuticals has received final approval from the USFDA for its Abbreviated New Drug Application for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg and 120 mg strengths. The product has been cleared as a therapeutically equivalent version of Cardizem Tablets, the reference drug marketed by Bausch Health US, LLC.
These tablets are prescribed for managing chronic stable angina as well as angina caused by coronary artery spasm, with full usage details available on the official label.
With this approval, Alembic’s overall tally of USFDA-approved ANDAs now stands at 230, including 210 final approvals and 20 tentative approvals, marking another addition to its regulated-market product portfolio.
TOPICS:
Alembic Pharma