APHTHASOL (nda020511)- (5%)

Generic Name	AMLEXANOX	Innovator	ULURU
Dosage	5%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2011-Nov-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Amlexanox oral paste, 5%, is indicated for the treatment of aphthous ulcers in people with normal immune systems.

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
5%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of APHTHASOL