NDA 11620, held by Bracco. Diatrizoate Meglumine.
As of Nov 14, 2026, NDA 11620 (Cardiografin), held by Bracco, was first approved by FDA on Dec 3, 1958, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 3, 1958 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cardiografin85% · injectable;injection | Diatrizoate Meglumine | Discontinued |
| Jul 11, 1985 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1985 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Aug 5, 1982 | Supplement 22Labeling · Standard review | Approved | None posted |
| Jul 29, 1980 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1978 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1978 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1977 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1977 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1976 | Supplement 12Labeling · Standard review | Approved | None posted |
| Sep 14, 1976 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 10, 1976 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1975 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1958 | Original applicationNew formulation or manufacturer · 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
