IC-GREEN (nda011525)- (10MG/VIAL,25MG/VIAL,40MG/VIAL,50MG/VIAL)

Generic Name	INDOCYANINE GREEN	Innovator	RENEW PHARMS
Dosage	10MG/VIAL,25MG/VIAL,40MG/VIAL,50MG/VIAL
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	IC-GREEN® a tricarbocyanine dye, is indicated: • For determining cardiac output, hepatic function and liver blood flow. • For ophthalmic angiography.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MG/VIAL	**	**	-	-	-
25MG/VIAL	**	**	-	-	-
40MG/VIAL	**	**	-	-	-
50MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of IC-GREEN