Hypaque

NDA 11386, held by Ge Healthcare. Diatrizoate Sodium.

As of Nov 13, 2026, NDA 11386 (Hypaque), held by Ge Healthcare, was first approved by FDA on Mar 26, 1956, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 26, 1956
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Mar 26, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Hypaque100% · for solution;oral, rectal	Diatrizoate Sodium	Discontinued
Hypaque40% · solution;oral, rectal	Diatrizoate Sodium	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Aug 23, 1996	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 15, 1995	Supplement 33Labeling · Standard review	Approved	None posted
Sep 30, 1994	Supplement 34Manufacturing · Standard review	Approved	None posted
Oct 5, 1993	Supplement 31Manufacturing · Standard review	Approved	None posted
May 29, 1991	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 2, 1988	Supplement 26Manufacturing · Standard review	Approved	None posted
May 9, 1988	Supplement 27Labeling	Approved	None posted
Aug 14, 1986	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 17, 1986	Supplement 24Labeling	Approved	None posted
Feb 10, 1986	Supplement 23Labeling	Approved	None posted
Dec 28, 1984	Supplement 22Labeling	Approved	None posted
Sep 12, 1984	Supplement 21Labeling	Approved	None posted
Jan 12, 1984	Supplement 15Labeling	Approved	None posted
Jun 30, 1982	Supplement 16Labeling	Approved	None posted
Jul 5, 1979	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 13, 1977	Supplement 13Labeling	Approved	None posted
Sep 29, 1976	Supplement 11Labeling	Approved	None posted
Mar 26, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11386
Drugs@FDA: Overview at FDA
Company: GE Healthcare

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