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  • TABLET;ORAL - 20MG
  • TABLET;ORAL - 40MG
  • TABLET;ORAL - 5MG
  • TABLET;ORAL - 12.5MG;20MG
  • TABLET;ORAL - 12.5MG;40MG
  • TABLET;ORAL - 25MG;40MG
  • TABLET;ORAL - EQ 10MG BASE;20MG
  • TABLET;ORAL - EQ 10MG BASE;40MG
  • TABLET;ORAL - EQ 5MG BASE;20MG
  • TABLET;ORAL - EQ 5MG BASE;40MG

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207480

FDA
11 Jul 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204801

FDA
01 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217399

FDA
18 Jan 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206720

FDA
02 Dec 2022

https://www.business-standard.com/article/news-cm/iol-chemicals-secures-patent-for-invention-related-to-preparation-of-sartan-drugs-122112400926_1.html

BUSINESS-STANDARD
27 Nov 2022

https://www.business-standard.com/article/companies/macleods-pharmaceuticals-recalls-products-in-us-for-manufacturing-issues-122031300189_1.html

BUSINESS-STANDARD
28 Mar 2022

http://www.koreabiomed.com/news/articleView.html?idxno=12631

Shim Hyun-tai KOREABIOMED
24 Nov 2021

https://www.otsuka.co.jp/en/company/newsreleases/2021/20210927_2.html

PRESS RELEASE
27 Sep 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-2-2021-1622637119.pdf

FDA
02 Jun 2021

https://www.tga.gov.au/alert/shortage-olmesartan-and-prazosin-tablets#:~:text=Olmesartan%20and%20prazosin%20tablets%20are,Substitution%20Notices%20for%20each%20medicine.

TGA
04 Sep 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208659

FDA
23 May 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-12-2020-1581485052.pdf

FDA
12 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207135

FDA
20 Jul 2019

https://www.raps.org/news-and-articles/news-articles/2019/5/fda-483s-pile-up-in-crackdown-on-sartan-manufactur

Ana Mulero RAPS
18 May 2019

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

PHARMABIZ
06 May 2019

https://www.tga.gov.au/alert/sartan-blood-pressure-medicines

TGA
26 Feb 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211049

FDA
25 Feb 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209281

FDA
07 Feb 2019

https://www.edqm.eu/en/news/update-edqm-review-cep-applications-sartan-substances-4-february-2019

EDQM
04 Feb 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-23-2019-1548227584.pdf

FDA
23 Jan 2019

https://www.taiwannews.com.tw/en/news/3620911

Ryan Drillsma TAIWAN NEWS
19 Jan 2019

https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm

FDA
21 Dec 2018

https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=print.getPrintData&ts=11122018102457

FDA
12 Dec 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209010

FDA
05 Dec 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-5-2018-1544180983.pdf

FDA
05 Dec 2018

https://www.ema.europa.eu/documents/press-release/eu-authorities-take-further-action-ongoing-review-sartans_en.pdf

EMA
15 Oct 2018

https://www.pharmacompass.com/pdf/news/Health-Canada-finds-Zhejiang-Huahai-Pharmaceuticals-site-non-compliant-with-GMP-1538639316.pdf

HEALTH CANADA
03 Oct 2018

https://www.raps.org/news-and-articles/news-articles/2018/9/eu-us-ban-manufacturer-use-of-valsartan-from-chin?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2028%20September

Ana Mulero RAPS
29 Sep 2018

https://www.raps.org/news-and-articles/news-articles/2018/9/ema-extends-valsartan-review-to-include-four-more?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2021%20September

Ana Mulero RAPS
22 Sep 2018

https://www.pharmacompass.com/pdf/news/EMA-review-of-impurities-in-sartan-medicines-1538045187.pdf

PRESS RELEASE
22 Sep 2018

http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2018/09/WC500255730.pdf

EMA
22 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209600

FDA
05 Sep 2018

https://www.pharmacompass.com/pdf/news/List-of-New-Paragraph-IV-Certifications-as-of-Aug-21-2018-1534919998.pdf

FDA
21 Aug 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208130

FDA
03 Jul 2018

https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines

TGA GOV
05 Jun 2018

http://www.pharmabiz.com/NewsDetails.aspx?aid=108089&sid=2

PHARMABIZ
30 Mar 2018

https://www.fiercepharma.com/pharma/daiichi-sankyo-makes-another-big-whack-at-u-s-sales-operation-280-to-go

Eric Palmer FIERCE PHARMA
06 Mar 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207435

FDA
07 Nov 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=104453&sid=2

PHARMABIZ
25 Sep 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209042

FDA
17 Aug 2017

http://www.fiercepharma.com/legal/fiscally-challenged-daiichi-sankyo-offers-300-million-to-settle-2-300-benicar-lawsuits

Eric Palmer FIERCE PHARMA
02 Aug 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207073

FDA
21 Jul 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207807

FDA
07 Jul 2017

http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/jubilant-gets-usfda-nod-for-generic-hypertension-drug/articleshow/58714211.cms

ECONOMIC TIMES
23 May 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207450

FDA
18 May 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206906

FDA
17 May 2017

http://www.business-standard.com/article/companies/lupin-gets-usfda-nod-to-sell-generic-hypertension-drug-in-us-117042800784_1.html

BUSINESS-STANDARD
29 Apr 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204233

FDA
27 Apr 2017

http://economictimes.indiatimes.com/news/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-gets-usfda-nod-for-anti-hypertension-drugs/articleshow/58357915.cms

ECONOMIC TIMES
26 Apr 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204798

FDA
26 Apr 2017
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