NDA 17042, held by Ge Healthcare. Sodium Fluoride F-18.
As of Nov 13, 2026, NDA 17042 (Fluorine F-18), held by Ge Healthcare, was first approved by FDA on Feb 24, 1972, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 1972 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorine F-182mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Sodium Fluoride F-18 | DiscontinuedReference drug |
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
