Details for New Drug Application (NDA): 080530

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NDA 080530 describes DOLENE, which is a drug marketed by Heritage Pharms Inc and Lederle and is included in two NDAs. Additional details are available on the DOLENE profile page.

The generic ingredient in DOLENE 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 080530

Tradename:	DOLENE
Applicant:	Heritage Pharms Inc
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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