USFDA15 Nov 2025, 09:31 am
Alembic Pharmaceuticals Receives USFDA Final Approval for Diltiazem Hydrochloride Tablets USP
AI Summary
Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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.
Key Highlights
- Alembic Pharmaceuticals received USFDA final approval for 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.