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  • ENEMA;RECTAL - 4GM/60ML
  • CAPSULE, EXTENDED RELEASE;ORAL - 250MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 500MG
  • CAPSULE, DELAYED RELEASE;ORAL - 400MG
  • SUPPOSITORY;RECTAL - 1GM
  • TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, DELAYED RELEASE;ORAL - 1.2GM
  • CAPSULE, EXTENDED RELEASE;ORAL - 375MG

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-6-2024-62498.pdf

FDA
06 Mar 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216334

FDA
05 Feb 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217533

FDA
06 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216941

FDA
30 May 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-receives-final-approval-from-usfda-for-generic-mesalamine-extended-release-capsules/articleshow/95245927.cms

ECONOMICTIMES
01 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216967

FDA
28 Oct 2022

https://www.expresspharma.in/sun-pharma-announces-us-fda-approval-for-generic-mesalamine-extended-release-capsules/

EXPRESS PHARMA
13 May 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209970

FDA
06 May 2022

http://www.pharmabiz.com/NewsDetails.aspx?aid=141812&sid=2

PHARMABIZ
14 Aug 2021

https://www.biospace.com/article/releases/teva-announces-launch-of-its-generic-version-of-canasa-mesalamine-suppositories-to-treat-adults-with-active-ulcerative-proctitis-ulcerative-rectal-colitis-in-the-united-states/

BIOSPACE
23 Apr 2021

https://www.businesswire.com/news/home/20210423005422/en

BUSINESSWIRE
22 Apr 2021

https://farmabios.com/2021/01/12/pharmazell-update-on-new-mesalazine-production-building-in-vizag-india/

PRESS RELEASE
12 Jan 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-18-2020-1605674129.pdf

FDA
18 Nov 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205654

FDA FDA
22 Aug 2020

https://www.expresspharma.in/latest-updates/lincoln-pharmaceuticals-receives-eu-gmp-approval/

EXPRESSPHARMA
18 May 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-11-2020-1583989701.pdf

FDA
12 Mar 2020

https://www.kyowakirin.com/media_center/news_releases/2020/pdf/e20200203_01.pdf

PRESS RELEASE
03 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210509

FDA
01 Jan 2020

https://www.federalregister.gov/documents/2019/12/02/2019-25946/morton-grove-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-21-abbreviated-new-drug

FEDERALREGISTER
02 Dec 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207271

FDA
21 Nov 2019

https://www.biospace.com/article/releases/amring-pharmaceuticals-announces-the-launch-of-two-valued-pharmaceutical-generics/

BIOSPACE
25 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202065

FDA
12 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207873

FDA
15 May 2019

https://www.businesswire.com/news/home/20190510005380/en/Teva-Announces-Launch-Generic-Version-Delzicol%C2%AE-mesalamine

BUSINESSWIRE
10 May 2019

http://pharmabiz.com/ArticleDetails.aspx?aid=115527&sid=1

PHARMABIZ
06 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211858

FDA
25 Jan 2019

https://www.prnewswire.com/news-releases/launch-of-generic-lialda-delayed-release-tablets-expands-mylans-gastroenterology-product-offering-300767416.html

PR NEWSWIRE
18 Dec 2018

https://www.prnewswire.com/news-releases/mylan-adds-first-generic-for-canasa-rectal-suppository-to-growing-gastroenterology-portfolio-300767412.html

PR NEWSWIRE
18 Dec 2018

https://www.prnewswire.com/news-releases/mylan-adds-first-generic-for-canasa-rectal-suppository-to-growing-gastroenterology-portfolio-300767412.html

PR NEWSWIRE
18 Dec 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208953

FDA
29 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208953

FDA
29 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207448

FDA
13 Nov 2018

https://www.fiercepharma.com/pharma/lack-late-stage-assets-at-takeda-don-t-worry-shire-has-it-covered

Angus Liu FIERCE PHARMA
01 Aug 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209970

FDA
17 Jul 2018

https://www.businesswire.com/news/home/20180326006022/en/Teva-Announces-Launch-Generic-Version-Lialda%C2%AE-United

BUSINESSWIRE
26 Mar 2018

http://www.fdalawblog.net/2018/03/fda-says-no-180-day-exclusivity-forfeiture-for-generic-lialda-based-on-changed-bioequivalence-recommendations/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29

Kurt R. Karst FDALAWBLOG
08 Mar 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208362

FDA
26 Aug 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202065

FDA
27 Jul 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203286

FDA
21 Jul 2017

http://www.business-standard.com/article/companies/cadila-healthcare-moraiya-plant-receives-eir-from-usfda-117062100598_1.html

BUSINESS-STANDARD
22 Jun 2017

http://www.biospectrumasia.com/news/25/9048/usfda-approves-the-generic-version-of-lialda-of-an-indian-drug-firm-zydus-cadila.html

BIOSPECTRUM
15 Jun 2017

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-cadila-gets-usfda-nod-for-mesalamine-tablets/articleshow/59031455.cms

ECONOMIC TIMES
06 Jun 2017

http://economictimes.indiatimes.com/news/industry/healthcare/biotech/healthcare/maternal-education-fights-malaria-better-than-vaccine-study/articleshow/58608375.cms

ECONOMIC TIMES
10 May 2017

https://www.pharmacompass.com/pdf/news/Delzicol-Mesalamine-Allergan-Qualicaps-V-Teva-Pharmaceuticals-Usa-1494842920.pdf

PATENT LITIGATION
21 Apr 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=99036&sid=2

PHARMAIZB
02 Dec 2016

http://www.pharmabiz.com/NewsDetails.aspx?aid=97962&sid=2

PHARMABIZ
06 Oct 2016

http://www.pharma-excipients.ch/2016/09/26/pectin-silica-gels-as-matrices-for-controlled-drug-release-in-gastrointestinal-trac/

PHARMA-EXCIPIENTS
26 Sep 2016

http://www.in-pharmatechnologist.com/Drug-Delivery/Shire-to-appeal-court-decision-in-favour-of-Zydus-Cadila-generic

Dan Stanton IN-PHARMATECHNOLOGIST
20 Sep 2016

https://www.pharmacompass.com/pdf/news/forest-labs-mesalamine-approved-in-us-1474376566.pdf

FDA
07 Sep 2016

http://www.pharma-excipients.ch/2016/08/09/tailoring-the-mucoadhesive-and-sustained-release-characteristics-of-mesalamine-loaded-formulations-for-local-treatment-of-distal-forms-of-ulcerative-colitis/

PHARMAEXCIPIENTS
08 Aug 2016
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