NDA 13993, held by Bracco. Sodium Chromate Cr-51.
As of Nov 13, 2026, NDA 13993 (Chromitope Sodium), held by Bracco, was first approved by FDA on Dec 27, 1971, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 1971 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Chromitope Sodium200uCi/ML · injectable;injection | Sodium Chromate Cr-51 | Discontinued |
| Chromitope Sodium2mCi/VIAL · injectable;injection | Sodium Chromate Cr-51 | Discontinued |
| Mar 6, 2001 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 25, 2000 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1997 | Supplement 18Labeling · Standard review | Approved | None posted |
| Sep 30, 1985 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Mar 8, 1984 | Supplement 16Labeling | Approved | None posted |
| Jan 30, 1984 | Supplement 15Labeling | Approved | None posted |
| May 16, 1980 | Supplement 12Labeling | Approved | None posted |
| May 30, 1978 | Supplement 11Labeling | Approved | None posted |
| Aug 29, 1977 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1977 | Supplement 9Labeling | Approved | None posted |
| Aug 29, 1977 | Supplement 8Labeling | Approved | None posted |
| Aug 27, 1977 | Supplement 7Labeling | Approved | None posted |
| Jan 18, 1977 | Supplement 6Labeling | Approved | None posted |
| Apr 21, 1976 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 27, 1971 | 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
