NDA 18058, held by Curium. Gallium Citrate Ga-67.
As of Nov 14, 2026, NDA 18058 (Gallium Citrate Ga 67), held by Curium, was first approved by FDA on Feb 1, 1979, with 9 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Gallium Citrate Ga 67 Injection may be useful to demonstrate the presence and extent of Hodgkin's disease, lymphoma, and bronchogenic carcinoma. Positive gallium Ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gallium Citrate Ga 672mCi/ML · injectable;injection | Gallium Citrate Ga-67 | Rx |
| Mar 19, 2014 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1985 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 8, 1984 | Supplement 5Labeling | Approved | None posted |
| Sep 27, 1982 | Supplement 7Labeling | Approved | None posted |
| Sep 14, 1982 | Supplement 8Labeling | Approved | None posted |
| May 7, 1982 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 4, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 4, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1979 | 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
