Diatrizoate

Overview

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
Optimizing Treatment of Adhesive Small Bowel Obstruction	2023/12/26	NCT06182319	Phase 3	Recruiting	University of California, Los Angeles
Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure	2023/02/13	NCT05726097	Phase 3	Completed	Region Skane
The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction	2018/08/22	NCT03642288	Not Applicable	UNKNOWN	Jinling Hospital, China
The Use of Gastrografin to Help Alleviate Bowel Obstruction in Gastroschisis Patients.	2017/11/07	NCT03334578	Phase 4	Withdrawn	Lawson Health Research Institute
Clinical and Financial Impact of an Evidenced-Based Adhesive Small Bowel Obstruction Management Protocol	2016/10/10	NCT02928458	Not Applicable	Withdrawn	The Guthrie Clinic
Uniformity of Oral Contrast Material in the Bowel	2015/09/04	NCT02542046	N/A	Completed	University of California, San Francisco
Gastrografin in Postoperative Ileus	2012/07/25	NCT01648972	Phase 2	Completed	University of Auckland, New Zealand
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants	2012/01/24	NCT01515696	Phase 4	Completed	Nadja Haiden,MD
Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery	2011/09/26	NCT01440712	Phase 4	Completed	Hospital Universitari de Bellvitge

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Gastrografin	Bracco Diagnostics Inc	0270-0445	ORAL, RECTAL	100 mg in 1 mL	4/23/2018
Diatrizoate Meglumine and Diatrizoate Sodium	Guardian Drug Company	53041-688	ORAL, RECTAL	100 mg in 1 mL	12/18/2020
MD GASTROVIEW	Liebel-Flarsheim Company LLC	0019-4816	ORAL, RECTAL	100 mg in 1 mL	2/15/2017
Diatrizoate Meglumine and Diatrizoate Sodium	Camber Pharmaceuticals, Inc.	31722-019	ORAL, RECTAL	100 mg in 1 mL	12/18/2023
Diatrizoate Meglumine and Diatrizoate Sodium	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	BERLIMED S A	SIN05846P	SOLUTION	0.1 g/ml	5/14/1991
GASTROGRAFIN SOLUTION	BERLIMED S A	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	Iotech Pty Ltd	Medicine	A	12/10/2001
Gastrografin Oral Liquid Bottle	471827	Bayer Australia Ltd	Medicine	A	12/20/2024
Gastrografin Oral Liquid Bottle	471827	Bayer Australia Ltd	Medicine	A	12/20/2024
IOSCAN sodium amidotrizoate 3.705 g/10 mL oral liquid sachet	65970	Iotech Pty Ltd	Medicine	A	9/21/1998
UROGRAFIN 30% 250mL injection bottle	42163	Bayer Australia Ltd	Medicine	A	9/22/1992
UROGRAFIN 30% 10mL injection ampoule	42161	Bayer Australia Ltd	Medicine	A	9/22/1992
Gastrografin Oral Liquid Bottle	10684	Bayer Australia Ltd	Medicine	A	8/19/1991
Gastrografin Oral Liquid Bottle	10684	Bayer Australia Ltd	Medicine	A	8/19/1991
UROGRAFIN 30% 10mL injection ampoule	42161	Bayer Australia Ltd	Medicine	A	9/22/1992
UROGRAFIN 30% 250mL injection bottle	42163	Bayer Australia Ltd	Medicine	A	9/22/1992

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
GASTROGRAFIN	E-Z-Em Canada Inc.	02228564	Solution - Rectal , Oral	10 %	12/30/1978
HYPAQUE PWR 100%	sterling winthrop inc.	01905007	Powder - Oral	100 %	12/31/1992
MD-76	tyco healthcare	00569739	Solution - Intra-Arterial , Intravenous	100 MG / ML	12/31/1982
RENOGRAFIN-60 LIQ	squibb diagnostics, division of bristol-myers squibb canada inc.	01974009	Liquid - Intravenous	8 %	12/31/1955
GASTROGRAFIN LIQ	squibb diagnostics, division of bristol-myers squibb canada inc.	01995669	Liquid - Refer (See Dosage Form) , Oral	10 %	12/31/1958
HYPAQUE-M LIQ 76% USP	sterling winthrop inc.	01904841	Liquid - Intravenous	10 %	12/31/1992
RENOCAL-76	E-Z-Em Canada Inc.	02232998	Liquid - Intravenous	10 %	7/1/1999
RENOGRAFIN-76 - LIQ IV	E-Z-Em Canada Inc.	02228637	Liquid - Intravenous	10 %	9/9/1998
HYPAQUE SODIUM 50% - LIQ IV	nycomed imaging a.s.	02180650	Liquid - Intravenous	50 %	4/22/1998
HYPAQUE ORAL POWDER 0.9974G/G	sanofi canada, inc.	02026988	Powder - Oral , Rectal	997.4 MG / G	12/31/1960

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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