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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 083689

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NDA 083689 describes PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, which is a drug marketed by Mylan, Sandoz, Vintage Pharms, and Watson Labs, and is included in five NDAs. Additional details are available on the PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN profile page.

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

Summary for 083689

Tradename:	PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Applicant:	Mylan
Ingredient:	acetaminophen; propoxyphene hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;32MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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