FDA — authorised 23 July 1975
- Application: ANDA084500
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ESTRACE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 estrace in United States
FDA authorised estrace on 23 July 1975
Marketing authorisations
FDA — authorised 28 July 1975
- Application: ANDA084499
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ESTRACE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 1984
- Application: ANDA086069
- Marketing authorisation holder: ABBVIE
- Local brand name: ESTRACE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 30 June 1993
- Application: ANDA081295
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ESTRACE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 December 1996
- Application: NDA020417
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: FEMPATCH
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 20 December 1996
- Application: NDA020655
- Marketing authorisation holder: ABBVIE
- Local brand name: ALORA
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 29 December 1997
- Application: ANDA040212
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: GYNODIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 1998
- Application: NDA020847
- Marketing authorisation holder: WOMEN FIRST HLTHCARE
- Local brand name: ESCLIM
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 29 December 1998
- Application: ANDA040275
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 1999
- Application: ANDA040326
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 1999
- Application: NDA021048
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: ESTRADIOL
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 22 October 1999
- Application: NDA021040
- Marketing authorisation holder: TEVA WOMENS
- Local brand name: PREFEST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 1999
- Application: ANDA040312
- Marketing authorisation holder: NOVO NORDISK INC
- Local brand name: INNOFEM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2000
- Application: ANDA075182
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: ESTRADIOL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 24 February 2000
- Application: ANDA075233
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: ESTRADIOL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 17 April 2002
- Application: ANDA040297
- Marketing authorisation holder: USL PHARMA
- Local brand name: ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 2005
- Application: ANDA076812
- Marketing authorisation holder: BARR
- Local brand name: ESTRADIOL AND NORGESTIMATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2005
- Application: NDA021885
- Marketing authorisation holder: BERLEX LABS
- Local brand name: CLIMARA PRO
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 15 December 2006
- Application: NDA021813
- Marketing authorisation holder: VIATRIS
- Local brand name: ELESTRIN
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 17 April 2008
- Application: ANDA078324
- Marketing authorisation holder: BRECKENRIDGE PHARM
- Local brand name: ESTRADIOL AND NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 2010
- Application: ANDA079193
- Marketing authorisation holder: BARR
- Local brand name: ESTRADIOL AND NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2012
- Application: ANDA200747
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ESTRADIOL AND NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 2012
- Application: NDA203752
- Marketing authorisation holder: NOVEN
- Local brand name: MINIVELLE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 19 December 2014
- Application: ANDA201675
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: ESTRADIOL
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 19 December 2014
- Application: ANDA020167
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: ESTRADIOL
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 29 May 2015
- Application: ANDA205256
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ESTRADIOL
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 20 June 2016
- Application: ANDA203339
- Marketing authorisation holder: LUPIN
- Local brand name: AMABELZ
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA206388
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ESTRADIOL
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 5 March 2018
- Application: ANDA209767
- Marketing authorisation holder: ENCUBE
- Local brand name: ESTRADIOL
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 30 March 2018
- Application: ANDA210488
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ESTRADIOL
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 15 August 2018
- Application: ANDA206685
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: ESTRADIOL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 28 October 2018
- Application: NDA210132
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: BIJUVA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 September 2020
- Application: ANDA211396
- Marketing authorisation holder: AMNEAL
- Local brand name: ESTRADIOL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 10 August 2022
- Application: ANDA211783
- Marketing authorisation holder: XIROMED
- Local brand name: ESTRADIOL
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 1 December 2022
- Application: ANDA206241
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ESTRADIOL
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 29 March 2023
- Application: ANDA202985
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ESTRADIOL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 17 April 2023
- Application: ANDA204379
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ESTRADIOL
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 30 June 2023
- Application: ANDA214729
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ETYQA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 September 2023
- Application: ANDA217334
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2023
- Application: ANDA216524
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: ESTRADIOL
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 22 April 2024
- Application: ANDA216160
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: ESTRADIOL
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 12 July 2024
- Application: ANDA217863
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: ESTRADIOL
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 12 July 2024
- Application: ANDA216055
- Marketing authorisation holder: AMNEAL
- Local brand name: ESTRADIOL
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 2 August 2024
- Application: ANDA216550
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ESTRADIOL
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 23 October 2024
- Application: ANDA217882
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: ESTRADIOL
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 2 February 2026
- Application: ANDA215096
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: ESTRADIOL
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
Other Other 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 28 July 1975; FDA authorised it on 31 January 1984.
Who is the marketing authorisation holder for estrace in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.