NDA 21870, held by Feinstein. Fludeoxyglucose F-18.
As of Nov 15, 2026, NDA 21870 (Fludeoxyglucose F18), held by Feinstein, was first approved by FDA on Aug 19, 2005, with 11 approved supplements and 0 published complete response letters.
Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2005 | Original applicationNew formulation or manufacturer | Approved |
| Fludeoxyglucose F1820-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Fludeoxyglucose F-18 | DiscontinuedReference drug |
| Fludeoxyglucose F1820-400mCi/ML · injectable;intravenous | Fludeoxyglucose F-18 | RxReference drug |
| Nov 9, 2023 | Supplement 18Labeling · Standard review | Approved | |
| Jun 27, 2019 | Supplement 15Labeling · Standard review | Approved | |
| Aug 1, 2016 | Supplement 12Manufacturing | Approved | None posted |
| Sep 10, 2015 | Supplement 11Manufacturing | Approved | None posted |
| Jul 8, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 15, 2014 | Supplement 9Manufacturing | Approved | |
| Nov 28, 2012 | Supplement 8Manufacturing | Approved | None posted |
| Jan 18, 2012 | Supplement 7Labeling · Standard review | Approved | |
| Jan 5, 2011 | Supplement 5Labeling | Approved | |
| Aug 18, 2010 | Supplement 4Labeling · Standard review | Approved | |
| Dec 21, 2006 | Supplement 1Manufacturing | Approved | None posted |
| Aug 19, 2005 | Original applicationNew formulation or manufacturer | 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
