CHOLETEC (nda018963)- (N/A)

Generic Name	TECHNETIUM TC-99M MEBROFENIN KIT	Innovator	BRACCO
Dosage	N/A
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2001-Jan-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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
N/A	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of CHOLETEC