FDA — authorised 12 August 2022
- Application: ANDA215737
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
🇺🇸 Antagonist in United States
FDA authorised Antagonist on 12 August 2022
Marketing authorisations
FDA — authorised 16 April 2024
- Application: ANDA217776
- Marketing authorisation holder: QILU
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 24 April 2024
- Application: ANDA214540
- Marketing authorisation holder: LIVZON GRP
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 25 April 2024
- Application: ANDA218150
- Marketing authorisation holder: GLAND
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 3 June 2025
- Application: ANDA218061
- Marketing authorisation holder: XIROMED
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 29 April 2026
- Application: ANDA218740
- Marketing authorisation holder: HUMANWELL
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Antagonist approved in United States?
Yes. FDA authorised it on 12 August 2022; FDA authorised it on 16 April 2024; FDA authorised it on 24 April 2024.
Who is the marketing authorisation holder for Antagonist in United States?
TEVA PHARMS INC holds the US marketing authorisation.