GASTROGRAFIN
Details
- Status
- Prescription
- First Approved
- 1958-01-17
- Routes
- ORAL, RECTAL
- Dosage Forms
- SOLUTION
GASTROGRAFIN Approval History
What GASTROGRAFIN Treats
2 FDA approvalsOriginally approved for its first indication in 1958 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jan 1958)
- • Approved indication (Sep 1983)
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.
GASTROGRAFIN FDA Label Details
ProIndications & Usage
Gastrografin (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. Gastrografin 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 of a radiopaque contrast a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.