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  • OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE
  • CREAM;TOPICAL - EQ 0.05% BASE;1%
  • CREAM;TOPICAL - EQ 0.05% BASE
  • OINTMENT;TOPICAL - EQ 0.05% BASE
  • CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • OINTMENT;TOPICAL - 0.064%;0.005%
  • SUSPENSION;TOPICAL - 0.064%;0.005%

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218289

FDA
10 Apr 2024

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-gets-usfda-nod-for-generic-drug-with-180-day-exclusivity/articleshow/98934035.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

ECONOMIC TIMES
23 Mar 2023

https://www.globenewswire.com/news-release/2022/09/15/2516825/0/en/EPI-Health-a-Novan-Company-and-MC2-Therapeutics-Present-WYNZORA-calcipotriene-and-betamethasone-dipropionate-Cream-0-005-0-064-Subgroup-Data-Analysis-at-Skin-of-Color-Update-2022-C.html

GLOBENEWSWIRE
15 Sep 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215847

FDA
12 Apr 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-30-2022-1648618596.pdf

FDA
30 Mar 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215186

FDA
18 Feb 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-5-2022-1641361383.pdf

FDA
05 Jan 2022

https://finance.yahoo.com/news/epi-health-mc2-therapeutics-announce-130000824.html

YAHOO
09 Nov 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-22-2021-1632297403.pdf

FDA
22 Sep 2021

https://www.accessdata.fda.gov/cms_ia/importalert_190.html

FDA
14 Sep 2021

https://leo-pharma.com/media-center/news/leo-pharma-announces-us-fda-approval-for-enstilar-foam

PRESS RELEASE
23 Oct 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212367

FDA
15 Sep 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213269

FDA
13 Sep 2020

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-enstilar-207589-calcipotriene-and-betamethasone-dipropionate-topical-foam00050064-1597494793.pdf

FDA
12 Aug 2020

https://www.b3cnewswire.com/202007222098/mc2-therapeutics-announces-u-s-food-and-drug-administration-approval-of-wynzora-cream-calcipotriene-and-betamethasone-dipropionate-w-w-0-005-0-064-for-adults-with-plaque-psoriasis.html

B3CNEWSWIRE
21 Jul 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214048

FDA
18 Jul 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211722

FDA
25 Jun 2020

https://www.businesswire.com/news/home/20200612005254/en/LEO-Pharma-Presents-Results-Study-Twice-Weekly-Enstilar%C2%AE

BUSINESSWIRE
12 Jun 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210765

FDA
15 May 2020

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-gets-usfda-nod-to-market-skin-ointment/articleshow/72901066.cms

ECONOMIC TIMES
21 Dec 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208849

FDA
12 Oct 2019

https://www.businesswire.com/news/home/20190924005192/en/Bicycle-Therapeutics-Present-Updated-Data-Phase-IIIa/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

BUSINESSWIRE
24 Sep 2019

https://www.fiercepharma.com/pharma-asia/fiercepharmaasia-hifibio-s-kite-backed-c-round-kyowa-kirin-s-parkinson-s-nod-relief-for

Angus Liu FIERCE PHARMA
30 Aug 2019

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=175618

FDA
27 Aug 2019

https://www.fiercepharma.com/manufacturing/glenmark-recalls-creams-are-either-too-wet-or-too-gritty

Eric Palmer FIERCE PHARMA
27 Aug 2019

https://www.dnaindia.com/business/report-glenmark-to-recall-drugs-in-us-market-2784936

DNAINDIA
26 Aug 2019

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-recalls-products-from-us-market/articleshow/70826067.cms

ECONOMICTIMES
26 Aug 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-21-2019-1566366765.pdf

FDA
21 Aug 2019

https://www.businesswire.com/news/home/20190731005636/en/LEO-Pharma-Announces-U.S.-Food-Drug-Administration/?feedref=JjAwJuNHiystnCoBq_hl-WFAllVCLJFCqzlmaJ8DKHU4plfPZtlGYRDUHCSmgbii6XkLWuQZD-HgGRnjQvCyg3iCfEFIaJW7-otp9V1XQiK2eHTJy3ZqOEt7kKgLu20J

BUSINESSWIRE
31 Jul 2019

https://www.fiercepharma.com/pharma/vertex-touts-success-symdeko-despite-ceo-turnover-orkambi-stumble

Kyle Blankenship FIERCE PHARMA
31 Jul 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-26-2019-1561616031.pdf

FDA
26 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211540

FDA
04 Apr 2019

https://www.prnewswire.com/news-releases/perrigo-announces-tentative-fda-approval-for-the-generic-version-of-sernivo-spray-0-05-300824707.html

PR NEWSWIRE
04 Apr 2019

https://www.businesswire.com/news/home/20190201005407/en

BUSINESSWIRE
04 Feb 2019

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-receives-final-approvals-from-usfda-for-skin-ointment-heart-medicine/articleshow/67499638.cms

ECONOMIC TIMES
11 Jan 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210217

FDA
19 Oct 2018

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/68036a-eng.php

HEALTH CANADA
18 Oct 2018

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67334a-eng.php

HEALTH CANADA
18 Aug 2018

https://insight.rpxcorp.com/litigation_documents/12926948

PATENT LITIGATION
23 May 2018

https://www.pharmacompass.com/pdf/news/sernivobetamethasone-dipropionate-promius-pharma-v-taro-pharmaceuticals-1527500767.pdf

PATENT LITIGATION
23 May 2018

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-sernivo-betamethasone-dipropionatetopical-spray-1524032787.pdf

FDA
18 Apr 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209896

FDA
09 Feb 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206118

FDA
14 Nov 2017

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

FDA
22 Feb 2017

http://www.pharmatimes.com/news/smc_green_light_for_leos_enstilar_1132237

Selina McKee PHARMATIMES
16 Sep 2016

http://www.prnewswire.com/news-releases/leo-pharma-receives-scientific-approval-of-enstilar-for-the-treatment-of-psoriasis-in-eu-572901011.html

PR NEWSWIRE
21 Mar 2016

https://www.pharmacompass.com/pdf/news/glenmarks-generic-clotrimazole-and-betamethasone-dipropionate-approved-in-us-1446812643.pdf

FDA
05 Nov 2015
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