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    • TABLET;ORAL - 16MG
    • TABLET;ORAL - 32MG
    • TABLET;ORAL - 4MG
    • TABLET;ORAL - 8MG
    • TABLET;ORAL - 16MG;12.5MG
    • TABLET;ORAL - 32MG;12.5MG
    • TABLET;ORAL - 32MG;25MG
    Full View ScreenFull Screen View
    Prinston's Generic Candesartan Cilexetil Receives Approval in the U.S.
    Prinston's Generic Candesartan Cilexetil Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206233

    FDA
    24 Aug 2023
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    Enforcement Report - Week of September 22, 2021
    Enforcement Report - Week of September 22, 2021

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

    FDA
    22 Sep 2021
    Share Share
    Enforcement Report - Week of April 21, 2021
    Enforcement Report - Week of April 21, 2021

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-21-2021-1619072775.pdf

    FDA
    22 Apr 2021
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    AstraZeneca divests Atacand commercial rights to Cheplapharm
    AstraZeneca divests Atacand commercial rights to Cheplapharm

    https://www.pharmaceutical-technology.com/news/astrazeneca-divests-atacand-cheplapharm/

    PHARMACEUTICAL-TECHNOLOGY
    05 Jan 2021
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    Atacand divestment to Cheplapharm in more than 70 countries completed
    Atacand divestment to Cheplapharm in more than 70 countries completed

    https://www.astrazeneca.com/media-centre/press-releases/2021/atacand-divestment-in-over-70-countries-completed.html#:~:text=AstraZeneca%20has%20completed%20the%20divestment,Cheplapharm%20Arzneimittel%20GmbH%20(Cheplapharm)

    PRESS RELEASE
    04 Jan 2021
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    Enforcement Report - Week of January 23, 2019
    Enforcement Report - Week of January 23, 2019

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

    FDA
    23 Jan 2019
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    43 popular heart drugs found to contain carcinogens in Taiwan
    43 popular heart drugs found to contain carcinogens in Taiwan

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

    Ryan Drillsma TAIWAN NEWS
    19 Jan 2019
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    FDA presents interim limits of nitrosamines in currently marketed ARBs
    FDA presents interim limits of nitrosamines in currently marketed ARBs

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

    FDA
    21 Dec 2018
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    Alembic Pharms' Generic Candesartan Cilexetil Receives Approval in US
    Alembic Pharms' Generic Candesartan Cilexetil Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210302

    FDA
    04 Dec 2018
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    Questions and Answers: Impurities found in certain generic angiotensin II receptor blocker (ARB) products
    Questions and Answers: Impurities found in certain generic angiotensin II receptor blocker (ARB) products

    https://www.fda.gov/Drugs/DrugSafety/ucm626122.htm

    FDA
    20 Nov 2018
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    Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
    Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity

    https://www.ema.europa.eu/documents/press-release/valsartan-mylan-laboratories-india-can-no-longer-be-used-eu-medicines-due-ndea-impurity_en.pdf

    EMA
    20 Nov 2018
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    EU authorities take further action in ongoing review of sartans
    EU authorities take further action in ongoing review of sartans

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

    EMA
    15 Oct 2018
    Share Share
    Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with GMP
    Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with GMP

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

    HEALTH CANADA
    03 Oct 2018
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    EMA review of impurities in sartan medicines
    EMA review of impurities in sartan medicines

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

    PRESS RELEASE
    22 Sep 2018
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    Prinston’s Generic Candesartan Cilexetil:Hydrochlorothiazide Receives Approval In US
    Prinston’s Generic Candesartan Cilexetil:Hydrochlorothiazide Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207455

    FDA
    13 Apr 2018
    Share Share
    ANI Pharmaceuticals Acquires Four NDAs from AstraZeneca for $46.5 Million
    ANI Pharmaceuticals Acquires Four NDAs from AstraZeneca for $46.5 Million

    https://www.prnewswire.com/news-releases/ani-pharmaceuticals-acquires-four-ndas-from-astrazeneca-for-465-million-300576084.html

    PR NEWSWIRE
    30 Dec 2017
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    Zydus Pharm’s Generic Candesartan Cilexetil; Hydrochlorothiazide Receives Approval In US
    Zydus Pharm’s Generic Candesartan Cilexetil; Hydrochlorothiazide Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203466

    FDA
    29 Nov 2017
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    Zydus Pharm’s Generic Candesartan Cilexetil Receives Approval In US
    Zydus Pharm’s Generic Candesartan Cilexetil Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091390

    FDA
    24 Aug 2017
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    Macleods's Generic Candesartan Cilexetil Receives Approval In US
    Macleods's Generic Candesartan Cilexetil Receives Approval In US

    http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203813

    FDA
    05 Dec 2016
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    Anvisa suspends lots of medication for high blood pressure
    Anvisa suspends lots of medication for high blood pressure

    http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/201616/anvisa+suspende+lotes+de+medicamento+para+hipertensao+arterial

    ANVISA
    12 May 2016
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    Sandoz Inc recalls lots of Candesartan Cilexetil Tablets due to Failed Impurities/Degradation Specifications
    Sandoz Inc recalls lots of Candesartan Cilexetil Tablets due to Failed Impurities/Degradation Specifications

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0659-2016&w=02172016&lang=eng

    FDA
    17 Feb 2016
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    Amerisource Health Services recalls Candesartan Cilexetil Tablets, 16 mg, 30 Tablets due to Failed Impurities/Degradation Specifications
    Amerisource Health Services recalls Candesartan Cilexetil Tablets, 16 mg, 30 Tablets due to Failed Impurities/Degradation Specifications

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0660-2016&w=02172016&lang=eng

    FDA
    17 Feb 2016
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    APO-Candesartan / HCTZ Product Recall (2015-05-19)
    APO-Candesartan / HCTZ Product Recall (2015-05-19)

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/53497r-eng.php

    HEALTHY CANADIANS
    19 May 2015
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    Apotex initiated recall of one additional lot of APO-Candesartan
    Apotex initiated recall of one additional lot of APO-Candesartan

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/53251r-eng.php

    HEALTH CANADA
    05 May 2015
    Share Share
    Apotex Product Recalled by Health Canada
    Apotex Product Recalled by Health Canada

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52887r-eng.php

    HEALTHY CANADIANS
    13 Apr 2015
    Share Share
    Nova Southeastern University Researcher Discovers Certain ARB Drugs Are More Effective Than Others at Treating Heart Failure
    Nova Southeastern University Researcher Discovers Certain ARB Drugs Are More Effective Than Others at Treating Heart Failure

    http://www.biospace.com/News/nova-southeastern-university-researcher-discovers/363202/source=MoreNews

    BIOSPACE
    03 Feb 2015
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    NSU Researcher Discovers Certain ARB Drugs Are More Effective Than Others at Treating Heart Failure
    NSU Researcher Discovers Certain ARB Drugs Are More Effective Than Others at Treating Heart Failure

    http://nsunews.nova.edu/nsu-researcher-discovers-certain-arb-drugs-are-more-effective-than-others-at-treating-heart-failure/

    Press Release NOVA SOUTHEASTERN UNIVERSITY
    02 Feb 2015
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    EMA Recommends Hundreds of Drugs to be Suspended Over
    EMA Recommends Hundreds of Drugs to be Suspended Over "Flawed Studies"

    http://blogs.wsj.com/pharmalot/2015/01/23/ema-recommends-hundreds-of-drugs-to-be-suspended-over-flawed-studies/

    Ed Silverman PHARMALOT
    24 Jan 2015
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    Takeda and Teva set out generics joint venture plan
    Takeda and Teva set out generics joint venture plan

    http://www.pharmafile.com/news/502118/takeda-and-teva-set-out-generics-joint-venture-plan?

    PHARMAFILE
    05 Jan 2015
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    German Drugmakers Appeal Drug Suspensions Linked to Indian Data
    German Drugmakers Appeal Drug Suspensions Linked to Indian Data

    http://in.reuters.com/article/2014/12/15/us-india-pharmaceuticals-germany-idINKBN0JT13P20141215

    Frank Siebelt, Maria Sheahan, Jason Neely Reuters
    15 Dec 2014
    Share Share
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