NDA 19292, held by Liebel-Flarsheim. Diatrizoate Meglumine; Diatrizoate Sodium.
As of Nov 13, 2026, NDA 19292 (Md-76r), held by Liebel-Flarsheim, was first approved by FDA on Sep 29, 1989, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 1989 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Md-76r66%;10% · injectable;injection | Diatrizoate Meglumine; Diatrizoate Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Jul 6, 2015 | Supplement 10Labeling | Approved | |
| May 10, 2013 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1996 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1995 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 4, 1992 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1992 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 11, 1992 | Supplement 4Labeling | Approved | None posted |
| Jun 4, 1990 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1990 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1990 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 29, 1989 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
