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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076743

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NDA 076743 describes PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN, which is a drug marketed by Able, Actavis Elizabeth, Cornerstone, Halsey, Ivax Sub Teva Pharms, Mallinckrodt, Mirror Pharms, Mutual Pharm, Mylan, Mylan Pharms Inc, Sandoz, Superpharm, Teva, Vintage Pharms, Watson Labs, Watson Labs Florida, and Wockhardt Ltd, and is included in twenty-six NDAs. Additional details are available on the PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN profile page.

The generic ingredient in PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN is acetaminophen; propoxyphene napsylate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.

Summary for 076743

Tradename:	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Applicant:	Cornerstone
Ingredient:	acetaminophen; propoxyphene napsylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;100MG
Approval Date:	May 7, 2004	TE:		RLD:	No

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