Used in scans for suspected prostate cancer recurrence and non-informative bone scintigraphy. Sold as Choline C-11. Every FDA application for this active ingredient: 1 branded and 4 generic.
As of Nov 14, 2026, FDA lists 5 applications for Choline C-11 (sold as Choline C-11), first approved Sep 12, 2012, with 0 new uses approved and 0 published complete response letters.
| Sep 12, 2012 | Choline C-11NDA 203155 ยท New molecular entity | Mcprf | 6 | Marketed |
| Oct 29, 2015 | Choline C-11ANDA 205690 | Univ Tx Md Anderson | 1 | Discontinued |
| Nov 13, 2015 | Choline C-11ANDA 206319 | Decatur | 3 | Marketed |
| Jan 10, 2017 | Choline C-11ANDA 208413 | Wa Univ Sch Med | 0 | Discontinued |
| Nov 20, 2017 | Choline C-11ANDA 208444 | Ucsf Rodiopharm | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
