ZYOGREEN (NDA218579)- (25MG/10ML (2.5MG/ML))

Generic Name	INDOCYANINE GREEN INJECTION	Innovator	PROVEPHARM SAS
Dosage	25MG/10ML (2.5MG/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZYOGREEN is an optical imaging agent indicated for: • Fluorescence imaging of vessels (micro-and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro-and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients • Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients from birth to less than 1 year of age and 6 years of age and older • Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer • Ophthalmic angiography in adults and pediatric patients

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
25MG/10ML (2.5MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ZYOGREEN