Approvals (Drugs@FDA)

DRONEDARONE HYDROCHLORIDE

LUPIN · DRONEDARONE HYDROCHLORIDE

ANDA205904Generic (ANDA)Discontinued
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Application number
ANDA205904
Sponsor name
LUPIN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240131
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      77486
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205904Orig1s000ltr.pdf
      Date
      20240214
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    DRONEDARONE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      DRONEDARONE HYDROCHLORIDE
      Strength
      EQ 400MG BASE
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.