DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (diatrizoate meglumine) · ANNORA PHARMA
Diatrizoate meglumine and diatrizoate sodium solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.
Details
- Status
- Prescription
- First Approved
- 2022-06-27
- Routes
- ORAL, RECTAL
- Dosage Forms
- SOLUTION
Companies
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM Approval History
What DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM Treats
1 indicationsDIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Esophagus Disease
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
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.
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM FDA Label Details
Indications & Usage
Diatrizoate meglumine and diatrizoate sodium solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. Diatrizoate meglumine and diatrizoate sodium solution may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.