Application Nr Approved Date Route Status External Links
NDA011245 1988-08-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And 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 Agent, When Unenhanced Imaging May Not Provide Sufficient Definition In Distinguishing Normal Loops Of Bowel From Adjacent Organs Or Areas Of Suspected Pathology.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Edetate Disodium EDETATE DISODIUM Molecular
2. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
3. Water WATER Molecular
4. Saccharin Sodium SACCHARIN SODIUM Molecular
5. Simethicone SIMETHICONE Unresolved

Active Ingredients ( 2 Total)

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