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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 207597

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NDA 207597 describes NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Corepharma, Granules, P And L, and Perrigo R And D, and is included in five NDAs. It is available from sixteen suppliers. Additional details are available on the NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; naproxen sodium. There are twenty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.

Summary for 207597

Tradename:	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	P And L
Ingredient:	diphenhydramine hydrochloride; naproxen sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;220MG
Approval Date:	Jan 25, 2019	TE:		RLD:	No

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