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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078769

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NDA 078769 describes OXYCODONE HYDROCHLORIDE AND IBUPROFEN, which is a drug marketed by Actavis Elizabeth, Barr Labs Inc, and Watson Labs, and is included in three NDAs. Additional details are available on the OXYCODONE HYDROCHLORIDE AND IBUPROFEN profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE AND IBUPROFEN 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 078769

Tradename:	OXYCODONE HYDROCHLORIDE AND IBUPROFEN
Applicant:	Actavis Elizabeth
Ingredient:	ibuprofen; oxycodone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG;5MG
Approval Date:	Jan 4, 2008	TE:		RLD:	No

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