Overview
A commonly used x-ray contrast medium. As diatrizoate meglumine and as Diatrizoate sodium, it is used for gastrointestinal studies, angiography, and urography.
Background
A commonly used x-ray contrast medium. As diatrizoate meglumine and as Diatrizoate sodium, it is used for gastrointestinal studies, angiography, and urography.
Indication
Used, alone or in combination, for a wide variety of diagnostic imaging methods, including angiography, urography, cholangiography, computed tomography, hysterosalpingography, and retrograde pyelography. It can be used for imaging the gastrointestinal tract in patients allergic to barium.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/26 | Phase 3 | Recruiting | |||
2023/02/13 | Phase 3 | Completed | |||
2018/08/22 | Not Applicable | UNKNOWN | Jinling Hospital, China | ||
2017/11/07 | Phase 4 | Withdrawn | |||
2016/10/10 | Not Applicable | Withdrawn | |||
2015/09/04 | N/A | Completed | |||
2012/07/25 | Phase 2 | Completed | University of Auckland, New Zealand | ||
2012/01/24 | Phase 4 | Completed | Nadja Haiden,MD | ||
2011/09/26 | Phase 4 | Completed | Hospital Universitari de Bellvitge |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bracco Diagnostics Inc | 0270-0445 | ORAL, RECTAL | 100 mg in 1 mL | 4/23/2018 | |
| Guardian Drug Company | 53041-688 | ORAL, RECTAL | 100 mg in 1 mL | 12/18/2020 | |
| Liebel-Flarsheim Company LLC | 0019-4816 | ORAL, RECTAL | 100 mg in 1 mL | 2/15/2017 | |
| Camber Pharmaceuticals, Inc. | 31722-019 | ORAL, RECTAL | 100 mg in 1 mL | 12/18/2023 | |
| Guardian Drug Company | 53041-690 | ORAL, RECTAL | 100 mg in 1 mL | 12/18/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GASTROGRAFIN SOLUTION | SIN05846P | SOLUTION | 0.1 g/ml | 5/14/1991 | |
| GASTROGRAFIN SOLUTION | SIN05846P | SOLUTION | 0.66 g/ml | 5/14/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| IOSCAN sodium amidotrizoate 370.5 mg/mL oral solution bottle | 80666 | Medicine | A | 12/10/2001 | |
| Gastrografin Oral Liquid Bottle | 471827 | Medicine | A | 12/20/2024 | |
| Gastrografin Oral Liquid Bottle | 471827 | Medicine | A | 12/20/2024 | |
| IOSCAN sodium amidotrizoate 3.705 g/10 mL oral liquid sachet | 65970 | Medicine | A | 9/21/1998 | |
| UROGRAFIN 30% 250mL injection bottle | 42163 | Medicine | A | 9/22/1992 | |
| UROGRAFIN 30% 10mL injection ampoule | 42161 | Medicine | A | 9/22/1992 | |
| Gastrografin Oral Liquid Bottle | 10684 | Medicine | A | 8/19/1991 | |
| Gastrografin Oral Liquid Bottle | 10684 | Medicine | A | 8/19/1991 | |
| UROGRAFIN 30% 10mL injection ampoule | 42161 | Medicine | A | 9/22/1992 | |
| UROGRAFIN 30% 250mL injection bottle | 42163 | Medicine | A | 9/22/1992 |