FDA — authorised 26 November 1971
- Marketing authorisation holder: VALEANT
- Status: approved
🇺🇸 Ancobon in United States
FDA authorised Ancobon on 26 November 1971
Marketing authorisations
FDA — authorised 26 November 1971
- Application: NDA017001
- Marketing authorisation holder: BAUSCH
- Local brand name: ANCOBON
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 2011
- Application: ANDA201566
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: FLUCYTOSINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 July 2017
- Application: ANDA204652
- Marketing authorisation holder: NOVEL LABS INC
- Status: approved
FDA — authorised 17 October 2017
- Application: ANDA206550
- Marketing authorisation holder: HIKMA
- Local brand name: FLUCYTOSINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 June 2018
- Application: ANDA207536
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: FLUCYTOSINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 April 2020
- Application: ANDA212632
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: FLUCYTOSINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 May 2020
- Application: ANDA213665
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FLUCYTOSINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 July 2025
- Application: ANDA218005
- Marketing authorisation holder: LAURUS
- Local brand name: FLUCYTOSINE
- Indication: CAPSULE — ORAL
- Status: approved
Ancobon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Ancobon approved in United States?
Yes. FDA authorised it on 26 November 1971; FDA authorised it on 26 November 1971; FDA authorised it on 28 June 2011.
Who is the marketing authorisation holder for Ancobon in United States?
VALEANT holds the US marketing authorisation.