NDA 9321, held by Bracco. Iodipamide Sodium, Iodipamide Meglumine.
As of Nov 14, 2026, NDA 9321 (Cholografin Sodium, Cholografin Meglumine), held by Bracco, was first approved by FDA on Apr 27, 1954, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 1954 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Cholografin Sodium20% · injectable;injection | Iodipamide Sodium | Discontinued |
| Cholografin Meglumine52% · injectable;injection | Iodipamide Meglumine | DiscontinuedReference drug |
| Cholografin Meglumine10.3% · injectable;injection | Iodipamide Meglumine | Discontinued |
| Apr 5, 2017 | Supplement 30Labeling · Standard review | Approved | |
| Jul 6, 2015 | Supplement 28Labeling · Standard review | Approved | |
| Mar 16, 2000 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 11, 1995 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 29, 1994 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1985 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 12, 1982 | Supplement 18Labeling | Approved | None posted |
| Oct 1, 1979 | Supplement 17Labeling | Approved | None posted |
| Jul 5, 1977 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| May 16, 1977 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Dec 2, 1976 | Supplement 14Labeling | Approved | None posted |
| Apr 27, 1954 | 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
