FDA — authorised 20 June 1952
- Status: approved
🇺🇸 Wellcovorin in United States
FDA authorised Wellcovorin on 20 June 1952
Marketing authorisations
FDA — authorised 31 May 1996
- Application: ANDA089384
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 7 April 1997
- Application: ANDA071198
- Marketing authorisation holder: BARR
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 26 October 2017
- Application: ANDA209110
- Marketing authorisation holder: SAGENT PHARMS INC
- Status: approved
FDA — authorised 14 March 2018
- Application: ANDA207241
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 27 July 2018
- Application: ANDA207226
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA
- Application: ANDA089833
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: WELLCOVORIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089834
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: WELLCOVORIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Wellcovorin 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 Wellcovorin approved in United States?
Yes. FDA authorised it on 20 June 1952; FDA authorised it on 31 May 1996; FDA authorised it on 7 April 1997.
Who is the marketing authorisation holder for Wellcovorin in United States?
Pfizer Japan Inc is the originator. The local marketing authorisation holder may differ — check the official source linked above.