ULTRAVIST 300 (nda020220)- (62.3%)

Generic Name	IOPROMIDE	Innovator	BAYER HLTHCARE
Dosage	62.3%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2005-Mar-06	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ULTRAVIST (iopromide) Injection is a radiographic contrast agent indicated for: • Cerebral arteriography and peripheral arteriography (300 mg Iodine per mL) • Coronary arteriography and left ventriculography, visceral angiography and aortography (370 mg Iodine per mL) • Excretory urography (300 mg Iodine per mL) • Contrast computed tomography (CT) imaging of head and body (300 mg Iodine per mL and 370 mg Iodine per mL).

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
62.3%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ULTRAVIST 300