Approvals (Drugs@FDA)

ONDANSETRON

SANDOZ · ONDANSETRON

ANDA078050Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA078050
Sponsor name
SANDOZ
Submissions
  1. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20120216
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20101029
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20070813
  4. Submission type
    SUPPL
    Submission number
    18
    Submission status
    AP
    Submission status date
    20240531
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  5. Submission type
    SUPPL
    Submission number
    16
    Submission status
    AP
    Submission status date
    20180514
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  6. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    20141210
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  7. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20111018
    Submission class code
    LABELING
    Submission class code description
    Labeling
  8. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20110331
    Submission class code
    LABELING
    Submission class code description
    Labeling
  9. Submission type
    SUPPL
    Submission number
    19
    Submission status
    AP
    Submission status date
    20251117
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  10. Submission type
    SUPPL
    Submission number
    17
    Submission status
    AP
    Submission status date
    20240531
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  11. Submission type
    SUPPL
    Submission number
    15
    Submission status
    AP
    Submission status date
    20170324
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  12. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20141210
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    ONDANSETRON
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ONDANSETRON
      Strength
      8MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    ONDANSETRON
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ONDANSETRON
      Strength
      4MG
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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.