Granules India gets ANDA nod for Amphetamine Mixed Salts ER Capsules by admin- Tuesday, January 24th, 2023 03:46:17 PM
Granules India announced that the United States Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by means of Granules
Pharmaceuticals, Inc (GPI)., a completely-owned overseas subsidiary of the agency, for Amphetamine Mixed Salts, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) drugs. It is bioequivalent to the reference listed drug product (RLD), Adderall XR Extended-Release pills of Takeda Pharmaceuticals
USA Inc. This product can be synthetic at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly.
Mixed Salts of a Single-Entity Amphetamine ER Capsules are indicated for the remedy of Attention Deficit Hyperactivity Disorder (ADHD).