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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 040569

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NDA 040569 describes PROPOXYPHENE HYDROCHLORIDE, which is a drug marketed by Alra, Impax Labs, Ivax Sub Teva Pharms, Mutual Pharm, Mylan, Nexgen Pharma Inc, Par Pharm, Purepac Pharm, Pvt Form, Roxane, Sandoz, Teva, Valeant Pharm Intl, Vintage Pharms, Watson Labs, West Ward, Whiteworth Town Plsn, and Warner Chilcott, and is included in thirty-two NDAs. Additional details are available on the PROPOXYPHENE HYDROCHLORIDE profile page.

The generic ingredient in PROPOXYPHENE HYDROCHLORIDE is aspirin; caffeine; propoxyphene hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; caffeine; propoxyphene hydrochloride profile page.

Summary for 040569

Tradename:	PROPOXYPHENE HYDROCHLORIDE
Applicant:	Mylan
Ingredient:	propoxyphene hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	65MG
Approval Date:	Dec 16, 2004	TE:		RLD:	No

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