FDA — authorised 29 July 1999
- Marketing authorisation holder: ORGANON USA INC
- Status: approved
🇺🇸 Ganirelix Acetate in United States
FDA authorised Ganirelix Acetate on 29 July 1999
Marketing authorisations
FDA — authorised 19 December 2014
- Application: NDA021057
- Marketing authorisation holder: ORGANON USA ORGANON
- Indication: Labeling
- Status: approved
FDA — authorised 7 April 2022
- Application: ANDA212613
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Status: approved
FDA — authorised 6 June 2022
- Application: ANDA214996
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 16 November 2023
- Application: ANDA216075
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 26 July 2024
- Application: ANDA204246
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
The FDA approved Ganirelix Acetate, a product of SUN PHARM, for the indication of labeling on 2024-07-26. This approval was granted through the standard expedited pathway. Ganirelix Acetate is a drug product that has not reported a local brand name.
Ganirelix Acetate 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 Ganirelix Acetate approved in United States?
Yes. FDA authorised it on 29 July 1999; FDA authorised it on 19 December 2014; FDA authorised it on 7 April 2022.
Who is the marketing authorisation holder for Ganirelix Acetate in United States?
ORGANON USA INC holds the US marketing authorisation.