Sinografin

NDA 11324, held by Bracco. Diatrizoate Meglumine; Iodipamide Meglumine.

As of Nov 13, 2026, NDA 11324 (Sinografin), held by Bracco, was first approved by FDA on Aug 22, 1958, with 23 approved supplements and 0 published complete response letters.

First approved: Aug 22, 1958
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Aug 22, 1958	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sinografin52.7%;26.8% · solution;intrauterine	Diatrizoate Meglumine; Iodipamide Meglumine	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Aug 29, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 17, 2002	Supplement 28Labeling · Standard review	Approved	Letter
Mar 16, 2000	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 29, 1994	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 6, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 28, 1985	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 3, 1983	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 22, 1983	Supplement 22Labeling	Approved	None posted
Jun 3, 1983	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 11, 1979	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 26, 1979	Supplement 20Labeling	Approved	None posted
Feb 15, 1979	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 15, 1979	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 28, 1978	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 28, 1978	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 25, 1978	Supplement 15Manufacturing · Standard review	Approved	None posted
May 31, 1978	Supplement 16Manufacturing · Standard review	Approved	None posted
May 31, 1978	Supplement 10Labeling	Approved	None posted
Apr 4, 1977	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 11, 1977	Supplement 11Manufacturing · Standard review	Approved	None posted
May 5, 1976	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 25, 1975	Supplement 8Manufacturing · Standard review	Approved	None posted
May 29, 1975	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 22, 1958	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 11324
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