Last Updated: September 24, 2026

Details for New Drug Application (NDA): 040061

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NDA 040061 describes ROXILOX, which is a drug marketed by Roxane and is included in one NDA. Additional details are available on the ROXILOX profile page.

The generic ingredient in ROXILOX is acetaminophen; oxycodone hydrochloride. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 040061

Tradename:	ROXILOX
Applicant:	Roxane
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG;5MG
Approval Date:	Jul 3, 1995	TE:		RLD:	No

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