Is there a generic for Ibuprofen; oxycodone hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Ibuprofen; oxycodone hydrochloride, referencing the brand COMBUNOX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ibuprofen; oxycodone hydrochloride?

COMBUNOX (NDA 021378, FOREST LABS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ibuprofen; oxycodone hydrochloride are approved?

Ibuprofen; oxycodone hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ibuprofen; oxycodone hydrochloride

Ibuprofen; oxycodone hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:COMBUNOX · NDA 021378

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
COMBUNOXRLD	FOREST LABS	NDA 021378	—	Nov 26, 2004

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
OXYCODONE HYDROCHLORIDE AND IBUPROFEN	ACTAVIS ELIZABETH	ANDA 078769	—	Jan 04, 2008
OXYCODONE HYDROCHLORIDE AND IBUPROFEN	BARR LABS INC	ANDA 078316	—	Nov 29, 2007
OXYCODONE HYDROCHLORIDE AND IBUPROFEN	WATSON LABS	ANDA 078394	—	Nov 26, 2007

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ibuprofen; oxycodone hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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