By: IPP Bureau
Last updated : August 09, 2023 1:45 pm
The US Food & Drug Administration (US FDA) has approved Granules India Ltd's Abbreviated New Drug Application (ANDA) for Metoprolol Succinate ER Tablets 25/50/100/200 mg. It is therapeutically equivalent to the reference listed drug, Toprol-XL Extended-Release Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of Sequel Therapeutics, LLC.
The company had filed two ANDAs for the same product with different technologies. This is the second ANDA approval for Metoprolol Succinate ER tablets that is therapeutically equivalent to the RLD, Toprol- XL, ER tablets for Granules.