FDA — authorised 25 June 1943
- Application: NDA005292
- Marketing authorisation holder: SCHERING
- Local brand name: ESTINYL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 estrogen therapy in United States
FDA authorised estrogen therapy on 25 June 1943 · 11 US adverse-event reports
Marketing authorisations
FDA — authorised 13 April 1944
- Application: NDA005490
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: LYNORAL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1968
- Application: NDA016672
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: OVRAL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 26 November 1968
- Application: NDA016806
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: OVRAL-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 24 April 1970
- Application: NDA016927
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: DEMULEN 1/50-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 8 December 1970
- Application: NDA016936
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: DEMULEN 1/50-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 April 1973
- Application: NDA017355
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: LOESTRIN FE 1.5/30
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 15 October 1974
- Application: NDA017488
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: MODICON 21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 15 October 1974
- Application: NDA017489
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: ORTHO-NOVUM 1/35-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 26 December 1974
- Application: NDA017566
- Marketing authorisation holder: ALLERGAN
- Local brand name: BREVICON 21-DAY
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 27 December 1974
- Application: NDA017565
- Marketing authorisation holder: ALLERGAN
- Local brand name: NORINYL 1+35 28-DAY
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 March 1975
- Application: NDA017612
- Marketing authorisation holder: CADENCE HEALTH
- Local brand name: LO/OVRAL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 28 August 1975
- Application: NDA017576
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Local brand name: OVCON-50
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 16 March 1976
- Application: NDA017802
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: LO/OVRAL-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 March 1976
- Application: NDA017716
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Local brand name: OVCON-35
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 March 1976
- Application: NDA017743
- Marketing authorisation holder: ALLERGAN
- Local brand name: BREVICON 28-DAY
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 1 October 1976
- Application: NDA017875
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: LOESTRIN 21 1.5/30
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 23 June 1977
- Application: NDA017919
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: ORTHO-NOVUM 1/35-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 February 1978
- Application: NDA017948
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: NORMINEST FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 July 1978
- Application: NDA018128
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: OVCON-50
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 5 July 1978
- Application: NDA018127
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: OVCON-35
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 30 December 1981
- Application: NDA018168
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: DEMULEN 1/35-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 30 December 1981
- Application: NDA018160
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: DEMULEN 1/35-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 11 January 1982
- Application: NDA018354
- Marketing authorisation holder: ORTHO MCNEIL JANSSEN
- Local brand name: ORTHO-NOVUM 10/11-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 10 May 1982
- Application: NDA018668
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: NORDETTE-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 21 July 1982
- Application: NDA018782
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: NORDETTE-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 4 April 1984
- Application: NDA019004
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: ORTHO-NOVUM 7/14-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 4 April 1984
- Application: NDA018985
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: ORTHO-NOVUM 7/7/7-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 11 April 1984
- Application: NDA018977
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: TRI-NORINYL 21-DAY
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 1 November 1984
- Application: NDA019190
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: TRIPHASIL-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 1 November 1984
- Application: NDA019192
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: TRIPHASIL-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 29 January 1987
- Application: ANDA070685
- Marketing authorisation holder: WATSON PHARMS TEVA
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 29 January 1987
- Application: ANDA070684
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 29 January 1987
- Application: ANDA070687
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 January 1987
- Application: ANDA070686
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 14 December 1987
- Application: ANDA071541
- Marketing authorisation holder: LPI
- Local brand name: N.E.E. 1/35 21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 14 December 1987
- Application: ANDA071542
- Marketing authorisation holder: LPI
- Local brand name: N.E.E. 1/35 28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 1 April 1988
- Application: ANDA071043
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 1 April 1988
- Application: ANDA071044
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 12 April 1988
- Application: ANDA071480
- Marketing authorisation holder: WATSON PHARMS TEVA
- Local brand name: NORETHIN 1/35E-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 12 April 1988
- Application: ANDA071481
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHIN 1/35E-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 9 February 1989
- Application: ANDA071546
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: NORCEPT-E 1/35 28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 9 February 1989
- Application: ANDA071545
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: NORCEPT-E 1/35 21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 29 December 1989
- Application: NDA019653
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: ORTHO CYCLEN-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 24 September 1991
- Application: ANDA071041
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 24 September 1991
- Application: ANDA071042
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 December 1991
- Application: ANDA072722
- Marketing authorisation holder: WATSON LABS
- Local brand name: ZOVIA 1/50E-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 30 December 1991
- Application: ANDA072720
- Marketing authorisation holder: WATSON PHARMS TEVA
- Local brand name: ZOVIA 1/35E-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 30 December 1991
- Application: ANDA072721
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: ZOVIA 1/35E-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 February 1992
- Application: ANDA072693
- Marketing authorisation holder: BARR
- Local brand name: NORTREL 1/35-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 28 February 1992
- Application: ANDA072692
- Marketing authorisation holder: BARR
- Local brand name: NORTREL 0.5/35-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 28 February 1992
- Application: ANDA072697
- Marketing authorisation holder: BARR LABS
- Local brand name: GENCEPT 10/11-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 February 1992
- Application: ANDA072696
- Marketing authorisation holder: BARR LABS
- Local brand name: NORTREL 1/35-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 February 1992
- Application: ANDA072695
- Marketing authorisation holder: BARR LABS
- Local brand name: NORTREL 0.5/35-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 February 1992
- Application: ANDA072694
- Marketing authorisation holder: BARR
- Local brand name: GENCEPT 10/11-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 13 December 1993
- Application: ANDA073594
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: LEVORA 0.15/30-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 13 December 1993
- Application: ANDA073592
- Marketing authorisation holder: WATSON LABS
- Local brand name: LEVORA 0.15/30-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 9 October 1996
- Application: NDA020130
- Marketing authorisation holder: APIL
- Local brand name: ESTROSTEP FE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 18 December 1997
- Application: ANDA074538
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: TRIVORA-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 13 July 1998
- Application: NDA020860
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: LEVLITE
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 1 September 1998
- Application: NDA020946
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: PREVEN EMERGENCY CONTRACEPTIVE KIT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 1999
- Application: ANDA075288
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: LOW-OGESTREL-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 15 October 1999
- Application: NDA021065
- Marketing authorisation holder: APIL
- Local brand name: FEMHRT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 1999
- Application: NDA021102
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: FEMHRT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2001
- Application: ANDA075548
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: MICROGESTIN FE 1.5/30
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 April 2001
- Application: ANDA075796
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: AVIANE-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 16 July 2001
- Application: ANDA075809
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: ENPRESSE-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 30 November 2001
- Application: ANDA075840
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: CRYSELLE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 20 March 2002
- Application: ANDA075803
- Marketing authorisation holder: BARR
- Local brand name: LESSINA-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 August 2002
- Application: ANDA075478
- Marketing authorisation holder: BARR
- Local brand name: NORTREL 7/7/7
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 30 May 2003
- Application: ANDA076381
- Marketing authorisation holder: BARR
- Local brand name: JUNEL 1.5/30
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 18 September 2003
- Application: ANDA076064
- Marketing authorisation holder: BARR
- Local brand name: JUNEL FE 1.5/30
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 December 2003
- Application: ANDA075808
- Marketing authorisation holder: BARR
- Local brand name: TRI-SPRINTEC
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 26 March 2004
- Application: ANDA076335
- Marketing authorisation holder: PH HEALTH
- Local brand name: TRI-PREVIFEM
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 April 2004
- Application: ANDA076198
- Marketing authorisation holder: BARR
- Local brand name: BALZIVA-21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 22 April 2004
- Application: ANDA076238
- Marketing authorisation holder: BARR
- Local brand name: BALZIVA-28
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 September 2004
- Application: ANDA076783
- Marketing authorisation holder: BARR
- Local brand name: ARANELLE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 April 2005
- Application: ANDA077075
- Marketing authorisation holder: PH HEALTH
- Local brand name: GILDESS FE 1.5/30
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 13 May 2005
- Application: NDA021690
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: ORTHO TRI-CYCLEN 21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 23 May 2005
- Application: ANDA076785
- Marketing authorisation holder: BARR
- Local brand name: KELNOR
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 February 2006
- Application: NDA021871
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: LOESTRIN 24 FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 2006
- Application: ANDA076627
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 August 2006
- Application: ANDA076626
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 6 September 2006
- Application: ANDA077101
- Marketing authorisation holder: WATSON LABS
- Local brand name: QUASENSE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2007
- Application: ANDA076405
- Marketing authorisation holder: BARR
- Local brand name: TRI-LEGEST 21
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 26 October 2007
- Application: ANDA076105
- Marketing authorisation holder: BARR
- Local brand name: TRI-LEGEST FE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 24 October 2008
- Application: NDA022262
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: LOSEASONIQUE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2009
- Application: ANDA076784
- Marketing authorisation holder: BARR LABS INC
- Local brand name: TRI LO SPRINTEC
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 1 September 2009
- Application: ANDA078267
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 November 2009
- Application: ANDA076221
- Marketing authorisation holder: BARR LABS INC
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 February 2010
- Application: ANDA078323
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 4 February 2010
- Application: ANDA076393
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 February 2010
- Application: ANDA078379
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 18 March 2010
- Application: ANDA076629
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 5 August 2010
- Application: ANDA078965
- Marketing authorisation holder: BARR
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2010
- Application: ANDA079064
- Marketing authorisation holder: XIROMED
- Local brand name: INTROVALE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 2010
- Application: ANDA076337
- Marketing authorisation holder: PH HEALTH
- Local brand name: CYCLAFEM 1/35
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 16 November 2010
- Application: ANDA076338
- Marketing authorisation holder: PH HEALTH
- Local brand name: CYCLAFEM 7/7/7
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 December 2010
- Application: NDA022573
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 9 March 2011
- Application: ANDA090479
- Marketing authorisation holder: WATSON LABS
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA090538
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: BRIELLYN
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 11 May 2011
- Application: ANDA077099
- Marketing authorisation holder: PH HEALTH
- Local brand name: ORSYTHIA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 31 May 2011
- Application: ANDA078834
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2011
- Application: ANDA200494
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 26 September 2011
- Application: ANDA078892
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2011
- Application: ANDA200407
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 October 2011
- Application: ANDA091674
- Marketing authorisation holder: LUPIN LTD
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2011
- Application: ANDA077502
- Marketing authorisation holder: PH HEALTH
- Local brand name: MYZILRA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 December 2011
- Application: ANDA090946
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: DASETTA 7/7/7
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 December 2011
- Application: ANDA090948
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: DASETTA 1/35
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 December 2011
- Application: ANDA090947
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: PHILITH
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 19 January 2012
- Application: ANDA091636
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ALYACEN 7/7/7
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 19 January 2012
- Application: ANDA091634
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ALYACEN 1/35
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 February 2012
- Application: ANDA091452
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: MARLISSA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 27 March 2012
- Application: ANDA091204
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: WERA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 March 2012
- Application: ANDA091105
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: ELINEST
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 May 2012
- Application: ANDA090523
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: MONO-LINYAH
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 May 2012
- Application: ANDA090524
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: TRI-LINYAH
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 6 November 2012
- Application: ANDA078376
- Marketing authorisation holder: PH HEALTH
- Local brand name: GILDAGIA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 January 2013
- Application: ANDA090794
- Marketing authorisation holder: XIROMED
- Local brand name: ESTARYLLA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 January 2013
- Application: ANDA090793
- Marketing authorisation holder: XIROMED
- Local brand name: TRI-ESTARYLLA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 10 April 2013
- Application: ANDA091467
- Marketing authorisation holder: LUPIN LTD
- Local brand name: DAYSEE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2013
- Application: NDA204426
- Marketing authorisation holder: APIL
- Local brand name: TAYTULLA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 2013
- Application: ANDA201512
- Marketing authorisation holder: LUPIN LTD
- Local brand name: PIRMELLA 1/35
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 24 April 2013
- Application: ANDA201510
- Marketing authorisation holder: LUPIN LTD
- Local brand name: PIRMELLA 7/7/7
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 8 May 2013
- Application: NDA203667
- Marketing authorisation holder: APIL
- Local brand name: MINASTRIN 24 FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2013
- Application: ANDA203006
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 August 2013
- Application: ANDA091453
- Marketing authorisation holder: NOVAST LABS
- Local brand name: LARIN FE 1.5/30
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 26 September 2013
- Application: ANDA201886
- Marketing authorisation holder: LUPIN
- Local brand name: VYFEMLA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA202996
- Marketing authorisation holder: NOVAST LABS
- Local brand name: LARIN 1.5/30
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 23 April 2014
- Application: ANDA203371
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 30 October 2014
- Application: ANDA202742
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 December 2014
- Application: ANDA090938
- Marketing authorisation holder: BARR LABS
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 December 2014
- Application: ANDA090293
- Marketing authorisation holder: PH HEALTH
- Local brand name: GILDESS 24 FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 2015
- Application: ANDA202994
- Marketing authorisation holder: NOVAST LABS
- Local brand name: LARIN 24 FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 2015
- Application: ANDA202741
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 February 2015
- Application: ANDA203163
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ASHLYNA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 2015
- Application: ANDA202086
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 April 2015
- Application: ANDA203038
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2015
- Application: ANDA200384
- Marketing authorisation holder: NAARI PTE
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 7 April 2015
- Application: ANDA200383
- Marketing authorisation holder: NAARI PTE
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 11 May 2015
- Application: ANDA200897
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 May 2015
- Application: ANDA201088
- Marketing authorisation holder: XIROMED
- Local brand name: VIENVA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 27 May 2015
- Application: ANDA200492
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2015
- Application: ANDA200493
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2015
- Application: ANDA091232
- Marketing authorisation holder: XIROMED
- Local brand name: TRI-LO-ESTARYLLA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 9 September 2015
- Application: ANDA202132
- Marketing authorisation holder: XIROMED
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 October 2015
- Application: ANDA200489
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 October 2015
- Application: ANDA200488
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 18 November 2015
- Application: ANDA201585
- Marketing authorisation holder: LUPIN
- Local brand name: BLISOVI FE 1.5/30
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 4 December 2015
- Application: ANDA202507
- Marketing authorisation holder: XIROMED
- Local brand name: ELIFEMME
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 10 December 2015
- Application: ANDA204213
- Marketing authorisation holder: LUPIN
- Local brand name: FYAVOLV
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 2015
- Application: ANDA203413
- Marketing authorisation holder: PH HEALTH
- Local brand name: CYCLAFEM 0.5/35
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 December 2015
- Application: ANDA203448
- Marketing authorisation holder: LUPIN
- Local brand name: KAITLIB FE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 28 December 2015
- Application: ANDA200486
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 20 January 2016
- Application: ANDA206969
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 27 January 2016
- Application: ANDA201896
- Marketing authorisation holder: MYLAN
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 27 January 2016
- Application: ANDA201897
- Marketing authorisation holder: XIROMED
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 9 February 2016
- Application: ANDA204704
- Marketing authorisation holder: XIROMED
- Local brand name: ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 February 2016
- Application: ANDA204057
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 March 2016
- Application: ANDA091332
- Marketing authorisation holder: LUPIN
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 2016
- Application: ANDA205943
- Marketing authorisation holder: LUPIN
- Local brand name: FAYOSIM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2016
- Application: ANDA205588
- Marketing authorisation holder: LUPIN
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 24 May 2016
- Application: ANDA206287
- Marketing authorisation holder: LUPIN
- Local brand name: MIBELAS 24 FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2016
- Application: ANDA205049
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2016
- Application: ANDA203435
- Marketing authorisation holder: NOVAST LABS
- Local brand name: LERIBANE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2016
- Application: ANDA201828
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: NORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 28 July 2016
- Application: ANDA204703
- Marketing authorisation holder: XIROMED
- Local brand name: ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 23 September 2016
- Application: ANDA206866
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AYUNA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA207055
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CYONANZ
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA207056
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NYLIA 1/35
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 October 2016
- Application: ANDA207054
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NYLIA 7/7/7
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 27 October 2016
- Application: ANDA205630
- Marketing authorisation holder: LUPIN
- Local brand name: NORGESTIMATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 4 November 2016
- Application: ANDA205762
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: TRI-LO-MILI
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 14 November 2016
- Application: ANDA206886
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AFIRMELLE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 27 December 2016
- Application: ANDA207259
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2017
- Application: ANDA207535
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NEXESTA FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2017
- Application: ANDA207260
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 2017
- Application: ANDA207066
- Marketing authorisation holder: NAARI PTE
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2017
- Application: ANDA206851
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SIMPESSE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2017
- Application: ANDA206852
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LO SIMPESSE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2017
- Application: ANDA206864
- Marketing authorisation holder: NAARI PTE
- Local brand name: NORETHINDRONE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 8 May 2017
- Application: ANDA202875
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: NORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 15 June 2017
- Application: ANDA207580
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AUROVELA FE 1.5/30
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 15 June 2017
- Application: ANDA207504
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AUROVELA 24 FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2017
- Application: ANDA207581
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AUROVELA 1.5/30
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 11 September 2017
- Application: ANDA207514
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 2017
- Application: ANDA206120
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 2017
- Application: ANDA206053
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 2017
- Application: ANDA204847
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: HAILEY 24 FE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 December 2017
- Application: ANDA205131
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2017
- Application: ANDA210369
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2017
- Application: ANDA203770
- Marketing authorisation holder: XIROMED
- Local brand name: JAIMIESS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2018
- Application: NDA208612
- Marketing authorisation holder: AVION PHARMS
- Local brand name: BALCOLTRA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 March 2018
- Application: ANDA208639
- Marketing authorisation holder: APOTEX
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2018
- Application: ANDA209297
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: HAILEY 1.5/30
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 5 June 2018
- Application: ANDA209031
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: HAILEY FE 1.5/30
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 June 2018
- Application: ANDA205069
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 June 2018
- Application: ANDA206850
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ICLEVIA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2018
- Application: ANDA209547
- Marketing authorisation holder: NOVAST LABS
- Local brand name: MALMOREDE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 7 January 2019
- Application: ANDA202817
- Marketing authorisation holder: SUN PHARM
- Local brand name: CERINTA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 6 February 2019
- Application: ANDA202988
- Marketing authorisation holder: SUN PHARM
- Local brand name: SYLEVIA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2019
- Application: ANDA209548
- Marketing authorisation holder: NOVAST LABS
- Local brand name: LO-MALMOREDE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 11 December 2019
- Application: ANDA210830
- Marketing authorisation holder: AMNEAL
- Local brand name: ELURYNG
- Indication: RING — VAGINAL
- Status: approved
FDA — authorised 14 February 2020
- Application: NDA204017
- Marketing authorisation holder: AGILE
- Local brand name: TWIRLA
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 30 March 2020
- Application: NDA209405
- Marketing authorisation holder: EXELTIS USA INC
- Local brand name: TYBLUME
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2020
- Application: ANDA210087
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: FINZALA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2020
- Application: ANDA202962
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CHABELINA FE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 October 2020
- Application: ANDA091692
- Marketing authorisation holder: NOVAST LABS
- Local brand name: DOLISHALE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2020
- Application: ANDA213317
- Marketing authorisation holder: XIROMED
- Local brand name: GEMMILY
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 December 2020
- Application: ANDA212706
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: MERZEE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 August 2021
- Application: ANDA213977
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ONSURA
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 9 December 2021
- Application: ANDA207577
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: VERARING
- Indication: RING — VAGINAL
- Status: approved
FDA — authorised 28 April 2022
- Application: ANDA213901
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 August 2022
- Application: ANDA211328
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: HALOETTE
- Indication: RING — VAGINAL
- Status: approved
FDA — authorised 2 September 2022
- Application: ANDA090541
- Marketing authorisation holder: NOVAST LABS
- Local brand name: TRI-LO-LINYAH
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 11 October 2022
- Application: ANDA207585
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RHUZDAH
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 June 2023
- Application: ANDA211157
- Marketing authorisation holder: XIROMED
- Local brand name: ENILLORING
- Indication: RING — VAGINAL
- Status: approved
FDA — authorised 31 July 2023
- Application: ANDA202980
- Marketing authorisation holder: LUPIN
- Local brand name: TURQOZ
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 6 December 2023
- Application: ANDA216558
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: OSHIH
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 2024
- Application: ANDA217087
- Marketing authorisation holder: LUPIN
- Local brand name: MINZOYA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2024
- Application: NDA218718
- Marketing authorisation holder: MILLICENT PR
- Local brand name: FEMLYV
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA
- Application: ANDA208661
- Marketing authorisation holder: NOVAST LABS LTD
- Local brand name: LO LARIN FE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 11
Most-reported reactions
- Drug Ineffective — 2 reports (18.18%)
- Arthritis — 1 report (9.09%)
- Back Disorder — 1 report (9.09%)
- Cervical Myelopathy — 1 report (9.09%)
- Fall — 1 report (9.09%)
- Femur Fracture — 1 report (9.09%)
- Gallbladder Disorder — 1 report (9.09%)
- Hip Fracture — 1 report (9.09%)
- Intervertebral Disc Degeneration — 1 report (9.09%)
- Intervertebral Disc Protrusion — 1 report (9.09%)
Other Endocrinology / Women's Health approved in United States
Frequently asked questions
Is estrogen therapy approved in United States?
Yes. FDA authorised it on 25 June 1943; FDA authorised it on 13 April 1944; FDA authorised it on 16 April 1968.
Who is the marketing authorisation holder for estrogen therapy in United States?
SCHERING holds the US marketing authorisation.