FDA — authorised 11 August 2000
- Marketing authorisation holder: EMD SERONO INC
- Status: approved
🇺🇸 Cetrotide in United States
FDA authorised Cetrotide on 11 August 2000
Marketing authorisations
FDA — authorised 11 August 2000
- Application: NDA021197
- Marketing authorisation holder: EMD SERONO INC
- Local brand name: CETROTIDE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 16 April 2024
- Application: ANDA217776
- Marketing authorisation holder: QILU
- Status: approved
FDA — authorised 24 April 2024
- Application: ANDA214540
- Marketing authorisation holder: LIVZON GRP
- Status: approved
FDA — authorised 25 April 2024
- Application: ANDA218150
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 6 November 2025
- Application: ANDA215737
- Marketing authorisation holder: TEVA PHARMS INC
- Indication: Labeling
- Status: approved
Teva Pharms Inc obtained marketing authorisation for Cetrotide in the United States on 06 November 2025. The approval was granted under application number ANDA215737. The indication approved for Cetrotide is for use in the labeling.
Cetrotide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Cetrotide approved in United States?
Yes. FDA authorised it on 11 August 2000; FDA authorised it on 11 August 2000; FDA authorised it on 16 April 2024.
Who is the marketing authorisation holder for Cetrotide in United States?
EMD SERONO INC holds the US marketing authorisation.