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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 083077

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NDA 083077 describes PROPOXYPHENE COMPOUND 65, which is a drug marketed by Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in three NDAs. Additional details are available on the PROPOXYPHENE COMPOUND 65 profile page.

The generic ingredient in PROPOXYPHENE COMPOUND 65 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 083077

Tradename:	PROPOXYPHENE COMPOUND 65
Applicant:	Ivax Sub Teva Pharms
Ingredient:	aspirin; caffeine; propoxyphene hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	389MG;32.4MG;65MG
Approval Date:	Dec 7, 1984	TE:		RLD:	No

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