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    Cysteine Hydrochloride

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    Enforcement Report - Week of November 29, 2023
    Enforcement Report - Week of November 29, 2023

    29 Nov 2023

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-29-2023-18805.pdf

    FDA
    29 Nov 2023
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    Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL, and ELCYS (cysteine hydrochloride Injection), USP 500 mg/10 mL Due to the Presence of Particulate Matter
    Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL, and ELCYS (cysteine hydrochloride Injection), USP 500 mg/10 mL Due to the Presence of Particulate Matter

    25 Oct 2023

    // FDA

    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-84-sodium-bicarbonate-injection-usp-50

    FDA
    25 Oct 2023
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    Eton Pharmaceuticals Announces FDA Approval of Cysteine Hydrochloride Injection
    Eton Pharmaceuticals Announces FDA Approval of Cysteine Hydrochloride Injection

    11 Apr 2022

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2022/04/11/2419949/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Cysteine-Hydrochloride-Injection.html

    GLOBENEWSWIRE
    11 Apr 2022
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    Eton Pharma's Generic Cysteine Hydrochloride Receives Approval in US
    Eton Pharma's Generic Cysteine Hydrochloride Receives Approval in US

    08 Apr 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214082

    FDA
    08 Apr 2022
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    Eton Pharma Confirms First-to-File Patent Challenge on Elcys
    Eton Pharma Confirms First-to-File Patent Challenge on Elcys

    07 May 2020

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2020/05/07/2029382/0/en/Eton-Pharmaceuticals-Confirms-First-to-File-Patent-Challenge-on-Elcys-Cysteine-Hydrochloride-Injection.html

    GLOBENEWSWIRE
    07 May 2020
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