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Approvals (Drugs@FDA)

ROMIDEPSIN

ZYDUS PHARMS · ROMIDEPSIN

ANDA220783Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220783
Sponsor name
ZYDUS PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20261019
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ROMIDEPSIN
    Reference standard
    No
    Dosage form
    POWDER
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      ROMIDEPSIN
      Strength
      10MG/VIAL
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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.