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    • INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • SYRUP;ORAL - 10MG/5ML
    • INJECTABLE;INJECTION - 25MG/ML
    • INJECTABLE;INJECTION - 50MG/ML
    • TABLET;ORAL - 25MG
    • TABLET;ORAL - 50MG
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    Graviti's Generic Hydroxyzine Hydrochloride Receives Approval in the U.S.
    Graviti's Generic Hydroxyzine Hydrochloride Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217652

    FDA
    17 Aug 2023
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    Enforcement Report - Week of December 30, 2020
    Enforcement Report - Week of December 30, 2020

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-30-2020-1609403374.pdf

    FDA
    30 Dec 2020
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    Erfa Canada recalls ATARAX (hydroxyzine) due to resulting in a potential risk
    Erfa Canada recalls ATARAX (hydroxyzine) due to resulting in a potential risk

    http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/58758a-eng.php

    HEALTH CANADA
    09 Jun 2016
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    Dr Reddy's Lab completes acquisition of UCB's select brands
    Dr Reddy's Lab completes acquisition of UCB's select brands

    http://businesstoday.intoday.in/story/dr-reddy-lab-completes-acquisition-of-ucb-select-brands/1/220770.html

    PTI BUSINESS TODAY
    19 Jun 2015
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    Akorn, Inc. initiates Class II recall of Hydroxyzine Hydrochloride due to Failed Impurities/Degradation Specifications
    Akorn, Inc. initiates Class II recall of Hydroxyzine Hydrochloride due to Failed Impurities/Degradation Specifications

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1129-2015&w=06172015&lang=eng

    FDA
    06 Jun 2015
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    Advanced Physician Solutions, Inc. initiates Class II recall of Hydroxyzine Hydrochloride due to Lack of Assurance of Sterility
    Advanced Physician Solutions, Inc. initiates Class II recall of Hydroxyzine Hydrochloride due to Lack of Assurance of Sterility

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1099-2015&w=06032015&lang=eng

    FDA
    16 May 2015
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    New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines
    New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/03/news_detail_002296.jsp&mid=WC0b01ac058004d5c1

    EMA
    27 Mar 2015
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    PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines
    PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/02/news_detail_002265.jsp&mid=WC0b01ac058004d5c1

    EMA
    16 Feb 2015
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