FDA — authorised 15 September 2005
- Application: NDA020011
- Marketing authorisation holder: ABBVIE ENDOCRINE INC
- Indication: Labeling
- Status: approved
🇺🇸 Lupron in United States
FDA authorised Lupron on 15 September 2005
Marketing authorisations
FDA — authorised 13 January 2017
- Application: NDA021343
- Marketing authorisation holder: TOLMAR
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 June 2022
- Application: ANDA212963
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 23 September 2025
- Application: ANDA217957
- Marketing authorisation holder: UBI
- Indication: Labeling
- Status: approved
The FDA approved Lupron for its labelled indication on 23 September 2025. The marketing authorisation holder is UBI. This approval was granted under the standard expedited pathway. Lupron's application number is ANDA217957.
FDA — authorised 13 November 2025
- Application: ANDA215826
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
Lupron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Lupron approved in United States?
Yes. FDA authorised it on 15 September 2005; FDA authorised it on 13 January 2017; FDA authorised it on 6 June 2022.
Who is the marketing authorisation holder for Lupron in United States?
ABBVIE ENDOCRINE INC holds the US marketing authorisation.