FDA — authorised 28 February 2023
- Application: ANDA215658
- Marketing authorisation holder: GLAND
- Local brand name: GANIRELIX ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ganirelix - Delayed Puberty Ganirelix Visit in United States
FDA authorised Ganirelix - Delayed Puberty Ganirelix Visit on 28 February 2023
Marketing authorisations
FDA — authorised 16 November 2023
- Application: ANDA216075
- Marketing authorisation holder: LUPIN
- Local brand name: GANIRELIX ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 April 2025
- Application: ANDA218855
- Marketing authorisation holder: QILU
- Local brand name: GANIRELIX ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2025
- Application: ANDA219454
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: GANIRELIX ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Frequently asked questions
Is Ganirelix - Delayed Puberty Ganirelix Visit approved in United States?
Yes. FDA authorised it on 28 February 2023; FDA authorised it on 16 November 2023; FDA authorised it on 23 April 2025.
Who is the marketing authorisation holder for Ganirelix - Delayed Puberty Ganirelix Visit in United States?
GLAND holds the US marketing authorisation.