NDA 17630, held by Ge Healthcare. Sodium Iodide I-123.
As of Nov 13, 2026, NDA 17630 (Sodium Iodide I 123), held by Ge Healthcare, was first approved by FDA on Mar 24, 1976, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 1976 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Sodium Iodide I 123100uCi · capsule;oral | Sodium Iodide I-123 | Discontinued |
| Sodium Iodide I 1232mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Sodium Iodide I-123 | Discontinued |
| Sodium Iodide I 123200uCi · capsule;oral | Sodium Iodide I-123 | Discontinued |
| Jun 15, 2005 | Supplement 13Labeling · Standard review | Approved | |
| Mar 10, 1997 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Feb 28, 1997 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Jan 8, 1993 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Nov 18, 1988 | Supplement 8Labeling | Approved | None posted |
| Jul 1, 1986 | Supplement 6Labeling | Approved | None posted |
| Oct 1, 1982 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Mar 22, 1982 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| May 6, 1980 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jul 11, 1979 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Aug 3, 1977 | Supplement 2Labeling | Approved | None posted |
| Mar 24, 1976 | Original applicationNew molecular entity · Priority 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
