Details for New Drug Application (NDA): 021378

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NDA 021378 describes COMBUNOX, which is a drug marketed by Forest Labs and is included in one NDA. Additional details are available on the COMBUNOX profile page.

The generic ingredient in COMBUNOX is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.

Summary for 021378

Tradename:	COMBUNOX
Applicant:	Forest Labs
Ingredient:	ibuprofen; oxycodone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 26, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021378

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Forest Labs	COMBUNOX	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	021378-001	Nov 26, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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