PENNSAID (nda020947)- (1.5%)

Generic Name	DICLOFENAC SODIUM	Innovator	NUVO PHARMS INC
Dosage	1.5%
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2030-Aug-09	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PENNSAID is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
9	1	6

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1.5%	**	**	-	4	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of PENNSAID