Granules India Limited Received ANDA approval for Losartan Potassium Tablets
Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg.
It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC. Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals).