Granules India gets USFDA green flag for sleep aid drugs Naproxen Sodium, Diphenhydramine Hydrochloride Tablets

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.

Published On 2020-09-27 04:45 GMT   |   Update On 2020-09-27 04:45 GMT
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Hyderabad: Granules India Limited has recently announced that the US Food & Drug Administration (US FDA) has approved the company's Abbreviated New Drug Application (ANDA) for Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220 mg/25 mg (OTC).

The product is the 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.

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.

Read also: Granules India Dexmethylphenidate HCl ER capsules get USFDA approval to treat ADHD

Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.

Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.






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