FDA — authorised 12 September 2012
- Application: NDA203155
- Marketing authorisation holder: MCPRF
- Local brand name: CHOLINE C-11
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 Choline C-11 in United States
FDA authorised Choline C-11 on 12 September 2012
Marketing authorisations
FDA — authorised 29 October 2015
- Application: ANDA205690
- Marketing authorisation holder: UNIV TX MD ANDERSON
- Local brand name: CHOLINE C-11
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 13 November 2015
- Application: ANDA206319
- Marketing authorisation holder: DECATUR
- Local brand name: CHOLINE C-11
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 January 2017
- Application: ANDA208413
- Marketing authorisation holder: WA UNIV SCH MED
- Local brand name: CHOLINE C-11
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 20 November 2017
- Application: ANDA208444
- Marketing authorisation holder: UCSF RODIOPHARM
- Local brand name: CHOLINE C-11
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Choline C-11 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Choline C-11 approved in United States?
Yes. FDA authorised it on 12 September 2012; FDA authorised it on 29 October 2015; FDA authorised it on 13 November 2015.
Who is the marketing authorisation holder for Choline C-11 in United States?
MCPRF holds the US marketing authorisation.