FDA — authorised 26 January 1989
- Application: NDA019732
- Marketing authorisation holder: ABBVIE ENDOCRINE INC
- Local brand name: LUPRON DEPOT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 GNRH-A Leuprolide Acetate in United States
FDA authorised GNRH-A Leuprolide Acetate on 26 January 1989
Marketing authorisations
FDA — authorised 22 October 1990
- Application: NDA020011
- Marketing authorisation holder: ABBVIE ENDOCRINE INC
- Local brand name: LUPRON DEPOT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 March 1995
- Application: NDA019943
- Marketing authorisation holder: ABBVIE ENDOCRINE INC
- Local brand name: LUPRON DEPOT
- Indication: INJECTABLE — INJECTION
- Status: approved
Frequently asked questions
Is GNRH-A Leuprolide Acetate approved in United States?
Yes. FDA authorised it on 26 January 1989; FDA authorised it on 22 October 1990; FDA authorised it on 30 March 1995.
Who is the marketing authorisation holder for GNRH-A Leuprolide Acetate in United States?
ABBVIE ENDOCRINE INC holds the US marketing authorisation.