FDA — authorised 20 December 1996
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
🇺🇸 Copaxone in United States
FDA authorised Copaxone on 20 December 1996
Marketing authorisations
FDA — authorised 3 October 2017
- Application: ANDA091646
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 21 September 2022
- Application: ANDA206921
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 7 May 2025
- Application: ANDA208468
- Marketing authorisation holder: CHEMI SPA
- Status: approved
FDA — authorised 16 May 2025
- Application: ANDA206873
- Marketing authorisation holder: SYNTHON PHARMS INC
- Indication: Labeling
- Status: approved
The FDA approved Copaxone for its indicated use as stated in the labelling. This approval was granted to SYNTHON PHARMS INC on 2025-05-16. The application number for this approval is ANDA206873.
FDA — authorised 11 February 2026
- Application: ANDA213382
- Marketing authorisation holder: HYBIO
- Status: approved
Copaxone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Copaxone approved in United States?
Yes. FDA authorised it on 20 December 1996; FDA authorised it on 3 October 2017; FDA authorised it on 21 September 2022.
Who is the marketing authorisation holder for Copaxone in United States?
TEVA PHARMS USA holds the US marketing authorisation.