Granules India receives USFDA approval for Amphetamine Sulfate Tablets

Granules India announced that USFDA has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary of Granules India Limited for Amphetamine Sulfate Tablets USP 5 mg and 10 mg. It is bioequivalent to the reference listed drug product (RLD), Evekeo Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

Amphetamine Sulfate tablets is a central nervous system stimulant used to treat sleep disorder, increase attention, decrease impulsiveness and hyperactivity in patients with Attention Deficit Hyperactivity Disorder (ADHD).

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