ANTHELIOS 40 (nda022009)- (2%;3%;10%;5%,2%;3%;10%;5%)

Generic Name	AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE	Innovator	LOREAL USA
Dosage	2%;3%;10%;5%,2%;3%;10%;5%
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2011-Mar-31
GAIN Expiry	None	Drug Complexity	No
Indication	ANTHELIOS 40 is indicated to • helps prevent sunburn • higher SPF gives more sunburn protection • helps provide protection from UVA rays (short and long wavelengths)

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%;3%;10%;5%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ANTHELIOS 40