SOLARAZE (nda021005)- (3%)

Generic Name	DICLOFENAC SODIUM	Innovator	FOUGERA PHARMS
Dosage	3%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2016-Nov-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SOLARAZE is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	6

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
3%	**	**	-	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of SOLARAZE