Details for New Drug Application (NDA): 209726

NDA 209726 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 twenty-one 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. Twenty-two suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; naproxen sodium profile page.

Summary for 209726

Tradename:	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	Amneal Pharms Co
Ingredient:	diphenhydramine hydrochloride; naproxen sodium
Patents:	0

Pharmacology for NDA: 209726

Mechanism of Action

Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 209726

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	209726	ANDA	Walgreens	0363-0844	0363-0844-80	80 TABLET in 1 BOTTLE, PLASTIC (0363-0844-80)
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	209726	ANDA	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-854	55910-854-20	1 BOTTLE, PLASTIC in 1 BOX (55910-854-20) / 20 TABLET in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	25MG;220MG
Approval Date:	Oct 23, 2018	TE:		RLD:	No

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