Granules India arm gets tentative approval from US drug regulator for drug used in treating ADHD

The US Food and Drug Administration (USFDA) has given its tentative approval for the company’s abbreviated new drug application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in the 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg and 18.8mg strengths. It is the generic equivalent of ADZENYS XR-ODT.

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