SYNALAR (nda012787)- (0.01%,0.025%,0.025%)

Generic Name	FLUOCINOLONE ACETONIDE	Innovator	MEDIMETRIKS PHARMS
Dosage	0.01%,0.025%,0.025%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SYNALAR® Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	2

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
0.01%	**	**	-	-	1
0.025%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of SYNALAR