Granules India receives USFDA approval for Amphetamine Mixed Salts IR Tablets

Granules India announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India, for Amphetamine Mixed Salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg Immediate-Release Tablets. It is bioequivalent to the reference listed drug product (RLD), _Adderall of Teva Women's Health Inc. The product would be available for the US market shortly.

Granules now have a total of 47 ANDA approvals from the US FDA (45 Final approvals and 2 tentative approvals).

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