COMBUNOX (nda021378)- (400MG;5MG)

Generic Name	IBUPROFEN; OXYCODONE HYDROCHLORIDE	Innovator	FOREST LABS
Dosage	400MG;5MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2005-Feb-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Combunox tablet is indicated for the short term (no more than 7 days) management of acute, moderate to severe pain.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
400MG;5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of COMBUNOX