SOLAGE (nda020922)- (2%;0.01%)

Generic Name	MEQUINOL; TRETINOIN	Innovator	ALMIRALL
Dosage	2%;0.01%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2020-Aug-24	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Solagé is a combination of mequinol, a skin lightening agent, and tretinoin, a retinoid, indicated for the treatment of solar lentigines, as an adjunct to a comprehensive skin care and sun avoidance program where the patient should primarily either avoid the sun or use protective clothing.

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
2%;0.01%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SOLAGE