Last Updated: September 28, 2026

Details for New Drug Application (NDA): 083538

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NDA 083538 describes PROPHENE 65, which is a drug marketed by Halsey and is included in one NDA. Additional details are available on the PROPHENE 65 profile page.

The generic ingredient in PROPHENE 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 083538

Tradename:	PROPHENE 65
Applicant:	Halsey
Ingredient:	propoxyphene hydrochloride
Patents:	0

Profile for product number 002

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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