Last Updated: September 29, 2026

Details for New Drug Application (NDA): 083786

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NDA 083786 describes PROPOXYPHENE HYDROCHLORIDE 65, which is a drug marketed by Warner Chilcott and is included in one NDA. Additional details are available on the PROPOXYPHENE HYDROCHLORIDE 65 profile page.

The generic ingredient in PROPOXYPHENE HYDROCHLORIDE 65 is propoxyphene hydrochloride. There is one drug master file entry for this compound. Additional details are available on the propoxyphene hydrochloride profile page.

Summary for 083786

Tradename:	PROPOXYPHENE HYDROCHLORIDE 65
Applicant:	Warner Chilcott
Ingredient:	propoxyphene hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	65MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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