RELAFEN (nda019583)- (500MG,750MG)

Generic Name	NABUMETONE	Innovator	SMITHKLINE BEECHAM
Dosage	500MG,750MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2003-Jun-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	RELAFEN is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	5

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	Yes

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
500MG	**	**	-	-	4
750MG	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of RELAFEN