NDA 19961, held by Chapter 7 Trustee. Gallium Nitrate.
As of Nov 13, 2026, NDA 19961 (Ganite), held by Chapter 7 Trustee, was first approved by FDA on Jan 17, 1991, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 17, 1991 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ganite25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Gallium Nitrate | Discontinued |
| Sep 17, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Mar 27, 1995 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 28, 1993 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 17, 1991 | 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
