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  • TABLET;ORAL-28 - 0.05MG;1MG
  • TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-28 - 0.35MG
  • TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
  • TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-21-2024-40984.pdf

FDA
21 Feb 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216796

FDA
06 Jan 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207585

FDA
11 Oct 2022

https://www.fiercepharma.com/pharma/pfizer-myovants-myfembree-back-track-endometriosis-nod-aug-execs-say

Fraiser Kansteiner FIERCEPHARMA
30 Jul 2022

https://extranet.who.int/prequal/news/bayer-estradiolnorethisterone-injection-pre-filled-syringes-prequalified

WHO
18 Aug 2020

https://www.prnewswire.com/news-releases/sumitovant-biopharma-announces-publication-of-myovant-abstracts-detailing-additional-efficacy-and-safety-findings-from-phase-3-liberty-studies-in-uterine-fibroids-in-obstetrics--gynecology-301049697.html

PR NEWSWIRE
29 Apr 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-15-2020-1579266573.pdf

FDA
16 Jan 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-14-2018-1542217134.pdf

FDA
14 Nov 2018

https://www.fda.gov/Safety/Recalls/ucm625012.htm

FDA
03 Nov 2018

https://www.pharmacompass.com/pdf/news/recipharm-ltd-fails-edqm-inspection-1540034321.pdf

EDQM
20 Oct 2018

https://www.federalregister.gov/documents/2018/10/19/2018-22805/sanofi-aventis-us-llc-et-al-withdrawal-of-approval-of-20-new-drug-applications

FEDERAL REGISTER
19 Oct 2018

https://www.bloomberg.com/news/articles/2018-04-02/allergan-is-said-to-weigh-options-for-women-s-health-unit

Kiel Porter BLOOMBERG
02 Apr 2018

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207535

FDA
02 Feb 2017

https://www.pharmacompass.com/pdf/news/aurobindos-generic-nylia-ethinyl-estradiol-norethindrone-received-approval-in-us-1477569102.pdf

FDA
22 Oct 2016

https://www.pharmacompass.com/pdf/news/aurobindo-pharmas-generic-incassia-norethindrone-approved-in-us-1475235470.pdf

FDA
27 Sep 2016

https://www.pharmacompass.com/pdf/news/jai-pharmas-generic-ethinyl-estradiol-and-norethindrone-acetate-approved-in-us-for-contraception-1464869173.pdf

FDA
01 Jun 2016

http://www.business-standard.com/article/pti-stories/glenmark-gets-usfda-tentative-nod-for-oral-contraceptives-116042600289_1.html

BUSINESS STANDARD
25 Apr 2016

https://www.pharmacompass.com/pdf/news/lupins-generic-norethindroneethinyl-estradiolferrous-fumarate-approved-in-us-to-prevent-pregnancy-1459160163.pdf

FDA
23 Mar 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-gets-usfda-nod-for-generic-oral-contraceptive-tablets/articleshow/49910908.cms

PTI ECONOMIC TIMES
24 Nov 2015

https://www.pharmacompass.com/pdf/news/jais-generic-norethindrone-ethinyl-estradiol-approved-in-us-for-contraception-1446115865.pdf

FDA
21 Oct 2015

http://www.mylan.com/news/press-releases/item?id=123294

Press Release MYLAN
07 Apr 2015

https://www.pharmacompass.com/pdf/news/n42.pdf

Press Release FAMY CARE LTD
01 Apr 2015
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