VISIPAQUE 320
Details
- Status
- Prescription
- First Approved
- 1996-03-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VISIPAQUE 320 Approval History
What VISIPAQUE 320 Treats
1 indicationsVISIPAQUE 320 is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
VISIPAQUE 320 Boxed Warning
NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( 5.1 )] . WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, pa...
WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( 5.1 )] . WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. ( 4 , 5.1 )
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VISIPAQUE 320 FDA Label Details
ProIndications & Usage
FDA Label (PDF)Iodixanol injection is indicated in for: Iodixanol 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 mg Iodine/mL 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/m...
WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications ( 4 ) and Adverse Reactions ( ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.