NDA 22494, held by Nih Nci Dctd. Sodium Fluoride F-18.
As of Nov 14, 2026, NDA 22494 (Sodium Fluoride F 18), held by Nih Nci Dctd, was first approved by FDA on Jan 26, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2011 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Fluoride F 1810-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Sodium Fluoride F-18 | DiscontinuedReference drug |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
