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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 076429

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NDA 076429 describes DARVOCET A500, which is a drug marketed by Xanodyne Pharm and is included in one NDA. Additional details are available on the DARVOCET A500 profile page.

The generic ingredient in DARVOCET A500 is acetaminophen; propoxyphene napsylate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene napsylate profile page.

Summary for 076429

Tradename:	DARVOCET A500
Applicant:	Xanodyne Pharm
Ingredient:	acetaminophen; propoxyphene napsylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG;100MG
Approval Date:	Sep 10, 2003	TE:		RLD:	No

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