Gastrografin

NDA 11245, held by Bracco. Diatrizoate Meglumine; Diatrizoate Sodium.

As of Nov 13, 2026, NDA 11245 (Gastrografin), held by Bracco, was first approved by FDA on Jan 17, 1958, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1958
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Sep 14, 1983	Supplement 20Efficacy (new indication or use)	Approved	None posted
Jan 17, 1958	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gastrografin66%;10% · solution;oral, rectal	Diatrizoate Meglumine; Diatrizoate Sodium	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Aug 29, 2005	Supplement 32Manufacturing · Standard review	Approved	Letter
Dec 15, 2000	Supplement 30Manufacturing · Standard review	Approved	None posted
Aug 5, 1994	Supplement 29Labeling · Standard review	Approved	None posted
May 19, 1994	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 5, 1991	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 28, 1985	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 14, 1983	Supplement 20Efficacy (new indication or use)	Approved	None posted
Sep 14, 1983	Supplement 23Labeling	Approved	None posted
Aug 3, 1983	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 2, 1983	Supplement 21Labeling	Approved	None posted
Sep 13, 1979	Supplement 19Labeling	Approved	None posted
Dec 28, 1978	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 16, 1978	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 27, 1978	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 8, 1976	Supplement 12Labeling	Approved	None posted
Sep 25, 1975	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 17, 1958	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11245
Drugs@FDA: Overview at FDA
Company: Bracco

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters