OPTIRAY 160 (nda019710)- (34%)

Generic Name	IOVERSOL	Innovator	LIEBEL-FLARSHEIM
Dosage	34%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2002-Dec-30	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults: • Cerebral Arteriography (300, 320 mg iodine/mL) • Peripheral Arteriography (300, 320, 350 mg iodine/mL) • Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) • Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures Adults: • Computed tomography (CT) Imaging of Head and Body (300, 320, 350 mg iodine/mL) • Venography (300, 320, 350 mg iodine/mL) • Intravenous Excretory Urography (300, 320, 350 mg iodine/mL) • Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320 mg iodine/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
34%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of OPTIRAY 160