Granules India gets USFDA’s nod for Naproxen Sodium, Diphenhydramine Hydrochloride Tablets

25 Sep 2020 Evaluate

Granules India has received approval from US Food & Drug Administration (US FDA) for 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. The company now has a total of 31 ANDA approvals from US FDA (29 Final approvals and 2 tentative approvals).

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

Granules India Share Price

544.40 -16.25 (-2.90%)
08-Dec-2025 16:59 View Price Chart
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