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    FDA Approval for HEPZATO issued to DELCATH SYSTEMS INC

    5/23/24 10:32:08 AM ET
    $DCTH
    Medical/Dental Instruments
    Health Care
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    New Drug Application (NDA): 201848
    Company: DELCATH SYSTEMS INC
    • Email
    • REMS

    Products on NDA 201848

    Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
    HEPZATO MELPHALAN HYDROCHLORIDE EQ 50MG BASE/VIAL POWDER;INTRA-ARTERIAL Prescription None Yes Yes

    Approval Date(s) and History, Letters, Labels, Reviews for NDA 201848

    Original Approvals or Tentative Approvals
    Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
    08/14/2023 ORIG-1 Approval Type 4 - New Combination STANDARD; Orphan Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201848s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201848Orig1s000ltr.pdf
    Supplements
    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
    01/22/2024 SUPPL-4 REMS - MODIFIED - D-N-A Letter (PDF)

    Label is not available on this site.

    https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s004Correctedltr.pdf
    05/22/2024 SUPPL-3 Labeling-Package Insert Label (PDF)
    Letter (PDF)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201848Orig1s003ltr.pdf

    Labels for NDA 201848

    Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
    Patient Package Insert
    Note Url
    05/22/2024 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201848Orig1s003lbl.pdf
    08/14/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201848s000lbl.pdf
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