FDA — authorised 23 July 1975
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
🇺🇸 Estrace in United States
FDA authorised Estrace on 23 July 1975
Marketing authorisations
FDA — authorised 16 October 1987
- Application: ANDA086069
- Marketing authorisation holder: ABBVIE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 31 July 2012
- Application: ANDA091634
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 22 June 2021
- Application: NDA210132
- Marketing authorisation holder: MAYNE PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 21 January 2022
- Application: ANDA205762
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 29 June 2023
- Application: ANDA211157
- Marketing authorisation holder: XIROMED
- Status: approved
Estrace 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 Estrace approved in United States?
Yes. FDA authorised it on 23 July 1975; FDA authorised it on 16 October 1987; FDA authorised it on 31 July 2012.
Who is the marketing authorisation holder for Estrace in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.