ISOVUE READI (NDA220583)- (200MG,250MG,300MG,370MG)

Generic Name	IOPAMIDOL	Innovator	BRACCO
Dosage	200MG,250MG,300MG,370MG
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	ISOVUE and ISOVUE READI are radiographic contrast agents. ISOVUE is indicated for: (1) Intra-arterial Procedures • Cerebral arteriography, peripheral arteriography, and selective arteriography and aortography, coronary arteriography, and cardiac ventriculography in adults • Angiocardiography in pediatric patients (2) Intravenous Procedures • Excretory urography and computed tomography (CT) of head and body in adults and pediatric patients • Peripheral venography in adults. ISOVUE and ISOVUE READI are indicated for: (3) Oral Procedures • CT of the abdomen and pelvis to delineate the gastrointestinal tract 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
200MG	**	**	-	-	-
250MG	**	**	-	-	-
300MG	**	**	-	-	-
370MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ISOVUE READI