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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 010997

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NDA 010997 describes DARVON, which is a drug marketed by Xanodyne Pharm and Aaipharma Llc and is included in six NDAs. Additional details are available on the DARVON profile page.

The generic ingredient in DARVON is aspirin; propoxyphene napsylate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; propoxyphene napsylate profile page.

Summary for 010997

Tradename:	DARVON
Applicant:	Xanodyne Pharm
Ingredient:	propoxyphene hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	32MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

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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