Mumbai, Sep 25 (UNI) Pharma major, Granules India on Friday said that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220 mg/25 mg (OTC), generic equivalent of Aleve PM Tablets, 220 mg/25 mg, of Bayer HealthCare LLC.
Naproxen Sodium and Diphenhydramine Hydrochloride Tablets are used for relief of occasional sleeplessness associated with minor aches and pains and to help you fall asleep and stay asleep, company said in afiling with BSE.
Granules now has a total of 31 ANDA approvals from US FDA (29 Final approvals and 2 tentative approvals).
Aleve PM is a registered trademark of Bayer HealthCare LLC.
