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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 204920

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NDA 204920 describes NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Dr Reddys, Pharmobedient, and Sciegen Pharms Inc, and is included in five NDAs. It is available from eight suppliers. Additional details are available on the NAPROXEN AND ESOMEPRAZOLE MAGNESIUM profile page.

The generic ingredient in NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

Summary for 204920

Tradename:	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Applicant:	Pharmobedient
Ingredient:	esomeprazole magnesium; naproxen
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE;375MG
Approval Date:	Jul 20, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 20MG BASE;500MG
Approval Date:	Jul 20, 2021	TE:		RLD:	No

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