Amipaque

NDA 17982, held by Ge Healthcare. Metrizamide.

As of Nov 14, 2026, NDA 17982 (Amipaque), held by Ge Healthcare, was first approved by FDA on Aug 23, 1978, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 23, 1978
Review: Priority
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Sep 12, 1983	Supplement 17Efficacy (new indication or use) · Priority review	Approved	None posted
Jan 17, 1983	Supplement 6Efficacy (new indication or use) · Priority review	Approved	None posted
Aug 23, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

4 strengths and forms


Amipaque3.75GM/VIAL · injectable;injection	Metrizamide	Discontinued
Amipaque6.75GM/VIAL · injectable;injection	Metrizamide	Discontinued
Amipaque2.5GM/VIAL · injectable;injection	Metrizamide	Discontinued
Amipaque13.5GM/VIAL · injectable;injection	Metrizamide	Discontinued

All 14 submissions, including labeling and manufacturing supplements


May 31, 1989	Supplement 24Labeling · Priority review	Approved	None posted
May 23, 1988	Supplement 21Manufacturing · Priority review	Approved	None posted
Aug 4, 1987	Supplement 22Labeling · Priority review	Approved	None posted
Nov 20, 1986	Supplement 23Labeling · Priority review	Approved	None posted
Sep 12, 1983	Supplement 19Manufacturing · Priority review	Approved	None posted
Sep 12, 1983	Supplement 17Efficacy (new indication or use) · Priority review	Approved	None posted
Jan 17, 1983	Supplement 6Efficacy (new indication or use) · Priority review	Approved	None posted
Jan 10, 1983	Supplement 18Manufacturing · Priority review	Approved	None posted
Jul 9, 1982	Supplement 11Labeling · Priority review	Approved	None posted
Nov 18, 1981	Supplement 7Manufacturing · Priority review	Approved	None posted
Oct 2, 1981	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 29, 1980	Supplement 5Labeling · Priority review	Approved	None posted
Feb 29, 1980	Supplement 2Labeling · Priority review	Approved	None posted
Aug 23, 1978	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17982
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