Category: Approval/Launch Region: Asia · India Company: Granules India Ltd

US FDA grants approval to Granules India for its generic Amphetamine Mixed Salts

US FDA grants approval to Granules India for its generic Amphetamine Mixed Salts
Amphetamine Mixed Salts IR tablets are prescribed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy Hyderabad: Granules India announced today that it has received approval from the US Food & Drug Administration (US FDA) on Abbreviated New Drug Application (ANDA) filed for Amphetamine Mixed Immediate Release Tablets. The regulatory body has granted approval to the Amphetamine Mixed Salts IR tablets in the capacity of 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg. It is a bioequivalent to the reference listed drug product (RLD) Adderall, a registered trademark of Teva Women

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