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    • INJECTABLE;INTRAVENOUS - 20MG/200ML (0.1MG/ML)
    • INJECTABLE;INJECTION - 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • INJECTABLE;INTRAVENOUS - 40MG/200ML (0.2MG/ML)
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    InfoRLife Generic Nicardipine Hydrochloride Receives Approval In US
    InfoRLife Generic Nicardipine Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203978

    FDA
    17 Apr 2024
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    SKG Pharma's Nicardipine Hydrochloride Receives Approval In the US
    SKG Pharma's Nicardipine Hydrochloride Receives Approval In the US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218202

    FDA
    10 Apr 2024
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    Enforcement Report - Week of March 27, 2024
    Enforcement Report - Week of March 27, 2024

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-27-2024-11790.pdf

    FDA
    27 Mar 2024
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    Senores announces the launch of Nicardipine Hydrochloride Capsules
    Senores announces the launch of Nicardipine Hydrochloride Capsules

    https://www.prnewswire.com/news-releases/senores-pharmaceuticals-inc-announces-the-launch-of-nicardipine-hydrochloride-capsules-usp-20-mg-and-30-mg-in-the-us-market-301937468.html

    PR NEWSWIRE
    25 Sep 2023
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    Senores' Generic Nicardipine Hydrochloride Receives Approval in the U.S.
    Senores' Generic Nicardipine Hydrochloride Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215377

    FDA
    17 Jul 2023
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    Micro Lab's Generic Nicardipine Hydrochloride Receives Approval in the U.S.
    Micro Lab's Generic Nicardipine Hydrochloride Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216420

    FDA
    07 Jul 2023
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    Square Pharmaceuticals Generic Nicardipine HCL Receives Approval in the U.S
    Square Pharmaceuticals Generic Nicardipine HCL Receives Approval in the U.S

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217555

    FDA
    03 May 2023
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    Glenmark Pharma gets USFDA nod for generic drug
    Glenmark Pharma gets USFDA nod for generic drug

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-pharma-gets-usfda-nod-for-generic-drug/articleshow/96334424.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

    ECONOMIC TIMES
    19 Dec 2022
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    Glenmark Pharma gets USFDA nod for generic drug
    Glenmark Pharma gets USFDA nod for generic drug

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-pharma-gets-usfda-nod-for-generic-drug/articleshow/96334424.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

    ECONOMIC TIMES
    19 Dec 2022
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    Glenmark's Generic Nicardipine Hydrochloride Receives Approval in the U.S.
    Glenmark's Generic Nicardipine Hydrochloride Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216357

    FDA
    16 Dec 2022
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    Astellas transfers three products in Asia region to Daiichi Sankyo
    Astellas transfers three products in Asia region to Daiichi Sankyo

    https://www.biospectrumasia.com/news/25/14696/astellas-transfers-three-products-in-asia-region-to-daiichi-sankyo.html

    BIOSPECTRUM ASIA
    17 Oct 2019
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    Enforcement Report - Week of May 1, 2019
    Enforcement Report - Week of May 1, 2019

    https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-May-1-2019-1556686753.pdf

    FDA
    01 May 2019
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    FDA Singles Out Three Drug Substances to Not be Compounded
    FDA Singles Out Three Drug Substances to Not be Compounded

    https://www.raps.org/news-and-articles/news-articles/2018/8/fda-singles-out-three-drug-substances-to-not-be-co?feed=Regulatory-Focus

    Zachary Brennan RAPS
    27 Aug 2018
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    Enforcement Report - Week of February 28, 2018
    Enforcement Report - Week of February 28, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-28-2018-1519803579.pdf

    FDA
    28 Feb 2018
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    Mylan recalling two injectable drugs made in India
    Mylan recalling two injectable drugs made in India

    http://www.fiercepharmamanufacturing.com/story/mylan-recalling-two-injectable-drugs-made-india/2015-03-31

    Eric Palmer FIERCE PHARMA MANUFACTURING
    31 Mar 2015
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    Mylan Institutional LLC, Ongoing Class III recall of Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10 because of Subpotent Drug and Failed Impurities/Degradation Specifications.
    Mylan Institutional LLC, Ongoing Class III recall of Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10 because of Subpotent Drug and Failed Impurities/Degradation Specifications.

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0413-2015&w=03252015&lang=eng

    FDA
    25 Mar 2015
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