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VISIPAQUE 270 (nda020351)- (55%)

IODIXANOL GE HEALTHCARE
55%
No No
2011-Nov-22 Expired
None None
None No
VISIPAQUE injection is a radiographic contrast agent indicated for the following: *Intra-arterial Procedures Adults and pediatric patients 12 years of age and over • Intra-arterial digital subtraction angiography (270 and 320 mg Iodine/mL). • Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL). Pediatric patients less than 12 years of age • Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL). *Intravenous Procedures Adults and pediatric patients 12 years of age and over • Computed tomography (CT) imaging head and body (270 and 320 mg Iodine/mL). • Excretory urography (270 and 320 mg Iodine/mL). • Peripheral venography (270 mg Iodine/mL). • Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of patients with suspected coronary artery disease (320 mg Iodine/mL). Pediatric patients less than 12 years of age • CT imaging of the head and body (270 mg Iodine/mL). • Excretory urography (270 mg Iodine/mL).
1 0 1
Total Other Developers None
Drugs with Suitability No
55% ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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