FDA — authorised 30 April 1998
- Application: ANDA064144
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 capecitabine and mitomycin in United States
FDA authorised capecitabine and mitomycin on 30 April 1998
Marketing authorisations
FDA — authorised 23 December 1999
- Application: ANDA064180
- Marketing authorisation holder: HIKMA
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 February 2012
- Application: NDA022572
- Marketing authorisation holder: GLAUKOS
- Local brand name: MITOSOL
- Indication: FOR SOLUTION — TOPICAL
- Status: approved
FDA — authorised 13 October 2017
- Application: ANDA203386
- Marketing authorisation holder: RK PHARMA
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 October 2017
- Application: ANDA202670
- Marketing authorisation holder: RK PHARMA
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 2021
- Application: ANDA215687
- Marketing authorisation holder: GLAND
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 September 2022
- Application: ANDA214504
- Marketing authorisation holder: MEITHEAL
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 September 2022
- Application: ANDA214505
- Marketing authorisation holder: MEITHEAL
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 November 2022
- Application: ANDA216648
- Marketing authorisation holder: GLAND
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 October 2023
- Application: ANDA216732
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: MITOMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 June 2025
- Application: NDA215793
- Marketing authorisation holder: UROGEN PHARMA
- Local brand name: ZUSDURI
- Indication: POWDER — INTRAVESICAL
- Status: approved
Frequently asked questions
Is capecitabine and mitomycin approved in United States?
Yes. FDA authorised it on 30 April 1998; FDA authorised it on 23 December 1999; FDA authorised it on 7 February 2012.
Who is the marketing authorisation holder for capecitabine and mitomycin in United States?
ACCORD HLTHCARE holds the US marketing authorisation.