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  • TABLET;ORAL-28 - 0.02MG;1MG
  • TABLET;ORAL-21 - 0.03MG;1.5MG
  • TABLET;ORAL-21 - 0.03MG;1.5MG
  • TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.02MG;1MG
  • INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
  • INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG
  • CAPSULE;ORAL - 0.02MG;1MG
  • TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
  • TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 1MG;0.5MG
  • TABLET;ORAL - 0.0025MG;0.5MG
  • TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-elagolix-sodium-estradiol-norethindrone-acetate-capsules-71055.pdf

FDA
08 Mar 2023

https://www.fiercepharma.com/pharma/myovant-pfizers-myfembree-wins-fda-nod-endometriosis

Zoey Becker FIERCEPHARMA
09 Aug 2022

https://www.expresspharma.in/glenmark-gets-us-fda-nod-for-norethindrone-acetate-and-ethinyl-estradiol-capsules-and-ferrous-fumarate-capsules-1-mg-20-mcg/

EXPRESS PHARMA
29 Jul 2022

https://www.pharmatimes.com/news/nice_draft_final_guidance_for_gedeon_richter_uks_new_uterine_fibroids_treatment_1448342

Ana Ovey PHARMATIMES
13 May 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-9-2022-1644385243.pdf

FDA
09 Feb 2022

https://www.globenewswire.com/news-release/2021/09/09/2294109/0/en/Myovant-Sciences-and-Pfizer-Announce-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-MYFEMBREE-for-the-Management-of-Moderate-to-Severe-Pain-Associated-With-Endometriosis.html

GLOBENEWSWIRE
09 Sep 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-25-2021-1629867988.pdf

FDA
25 Aug 2021

https://www.ema.europa.eu/en/documents/overview/ryeqo-epar-medicine-overview_en.pdf

EMA
29 Jul 2021

https://www.prnewswire.com/news-releases/slayback-pharma-announces-launch-of-merzee-norethindrone-acetate-and-ethinyl-estradiol-capsules-and-ferrous-fumarate-capsules-1-mg20-mcg-generic-equivalent-of-taytulla-301222104.html

PRNNEWSWIRE
04 Feb 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-19-2020-1597808962.pdf

FDA
19 Aug 2020

https://www.fda.gov/news-events/press-announcements/fda-approves-new-option-treat-heavy-menstrual-bleeding-associated-fibroids-women

FDA
01 Jun 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202962

FDA
18 Apr 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210087

FDA
09 Apr 2020

https://health.economictimes.indiatimes.com/news/pharma/glenmark-gets-usfda-nod-for-contraceptive-tablets/70799219

ECONOMICTIMES
24 Aug 2019

https://health.economictimes.indiatimes.com/news/pharma/glenmark-gets-usfda-nod-for-contraceptive-tablets/70799219

ECONOMICTIMES
22 Aug 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206490

FDA
08 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209609

FDA
21 Jul 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205069

FDA
26 Jun 2018

https://www.pharmacompass.com/pdf/news/allergan-issues-nationwide-voluntary-recall-of-taytulla-softgel-capsules-1mg20mcg-1527660267.pdf

FDA
30 May 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210233

FDA
05 Mar 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210369

FDA
29 Dec 2017

http://www.equitybulls.com/admin/news2006/news_det.asp?id=219591

EQUITYBULLS
28 Dec 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204847

FDA
21 Nov 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206120

FDA
16 Sep 2017

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-initiates-recall-of-tablet-mibelas-24-fe-from-us-market/articleshow/60206856.cms

ECONOMIC TIMES
24 Aug 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-23-2017-1503459270.pdf

FDA
23 Aug 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207580

FDA
19 Jun 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209014

FDA
09 Jun 2017

http://www.pharmtech.com/lupin-recalls-mibelas-24-fe

PHARM TECH
02 Jun 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-31-2017-1496224025.pdf

FDA
31 May 2017

https://www.pharmacompass.com/pdf/news/lupin-pharmaceuticals-inc-announces-a-nationwide-recall-of-mibelas-24-fe-tablets-due-to-out-of-sequence-tablets-and-missing-expirylot-information-1496122678.pdf

FDA
30 May 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-22-2017-1487758756.pdf

FDA
22 Feb 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207261

FDA
10 Feb 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207260

FDA
02 Feb 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207259

FDA
27 Dec 2016

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208661

FDA
20 Dec 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-launches-amabelz-tablets-in-us-market/articleshow/55439186.cms

ECONOMIC TIMES
16 Nov 2016

http://www.prnewswire.com/news-releases/allergan-announces-launch-of-taytulla-norethindrone-acetate-and-ethinyl-estradiol-capsules-and-ferrous-fumarate-capsules-1-mg20-mcg-the-first-and-only-oral-contraceptive-softgel-capsule-300360428.html

PR NEWSWIRE
11 Nov 2016

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205278

FDA
10 Nov 2016

http://www.fiercepharma.com/manufacturing/endo-s-par-recalls-half-a-million-birth-control-pills-made-by-patheon

Eric Palmer FIERCE PHARMA
02 Nov 2016

https://www.pharmacompass.com/pdf/news/lupins-generic-ambelz-approved-in-us-for-moderate-to-severe-vasomotor-symptoms-1467005865.pdf

FDA
20 Jun 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-launches-generic-femhrt-tablets-in-us/articleshow/51877658.cms

ECONOMIC TIMES
18 Apr 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-pharma-gets-usfda-nod-for-two-generic-drugs/articleshow/50665913.cms

ECONOMIC TIMES
20 Jan 2016

https://www.pharmacompass.com/pdf/news/aurobindo-pharma-receives-usfda-approval-for-norethindrone-acetate-tablets-1452747746.pdf

Aurobindo Pharma
11 Jan 2016

https://www.pharmacompass.com/pdf/news/lupins-generic-ethinyl-estradiol-and-norethindrone-acetate-approved-in-us-1448540766.pdf

FDA
18 Nov 2015

https://www.pharmacompass.com/pdf/news/n24.pdf

Press Release FDA
19 Feb 2015
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