NDA 22066, held by Ge Healthcare. Gadodiamide.
As of Nov 14, 2026, NDA 22066 (Omniscan), held by Ge Healthcare, was first approved by FDA on Sep 5, 2007, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Omniscan14.35GM/50ML (287MG/ML) · injectable;injection | Gadodiamide | DiscontinuedReference drug |
| Omniscan28.7GM/100ML (287MG/ML) · injectable;injection | Gadodiamide | DiscontinuedReference drug |
| Mar 5, 2025 | Supplement 15Labeling · Standard review | Approved | |
| Aug 14, 2024 | Supplement 12Labeling · Standard review | Approved | |
| Jul 23, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Jan 26, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Oct 23, 2019 | Supplement 10Labeling · Standard review | Approved | |
| Nov 7, 2018 | Supplement 9Labeling · Standard review | Approved | |
| Apr 26, 2018 | Supplement 8Labeling · Standard review | Approved | |
| Nov 14, 2014 | Supplement 7Labeling · Standard review | Approved | |
| May 14, 2014 | Supplement 5Manufacturing | Approved | None posted |
| Aug 27, 2013 | Supplement 4Labeling · Standard review | Approved | |
| Dec 11, 2012 | Supplement 6Labeling · Standard review | Approved | |
| Dec 20, 2010 | Supplement 2Labeling | Approved | |
| Sep 5, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
