NDA 21768, held by Weill Medcl Coll. Fludeoxyglucose F-18.
As of Nov 14, 2026, NDA 21768 (Fludeoxyglucose F18), held by Weill Medcl Coll, was first approved by FDA on Aug 5, 2004, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 5, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludeoxyglucose F1810-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Fludeoxyglucose F-18 | DiscontinuedReference drug |
| Dec 21, 2006 | Supplement 2Manufacturing | Approved | |
| Aug 5, 2004 | Original applicationNew dosage form · Standard review | Approved |
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
