Approvals (Drugs@FDA)

LIORESAL

NOVARTIS · BACLOFEN

NDA017851Drug (NDA)Discontinued
Open FDA's page for this record
Application number
NDA017851
Sponsor name
NOVARTIS
Submissions
  1. Submission type
    SUPPL
    Submission number
    21
    Submission status
    AP
    Submission status date
    19820318
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  2. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    19810514
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  3. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    19801006
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  4. Submission type
    SUPPL
    Submission number
    9
    Submission status
    AP
    Submission status date
    19800523
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  5. Submission type
    SUPPL
    Submission number
    38
    Submission status
    AP
    Submission status date
    19950818
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  6. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    19810203
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  7. Submission type
    SUPPL
    Submission number
    36
    Submission status
    AP
    Submission status date
    19900405
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  8. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    19791231
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  9. Submission type
    SUPPL
    Submission number
    28
    Submission status
    AP
    Submission status date
    19841116
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  10. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    19790321
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  11. Submission type
    SUPPL
    Submission number
    34
    Submission status
    AP
    Submission status date
    19891117
    Submission class code
    LABELING
    Submission class code description
    Labeling
  12. Submission type
    SUPPL
    Submission number
    26
    Submission status
    AP
    Submission status date
    19840215
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  13. +22 more not shown
Products
  1. Product number
    003
    Reference drug
    Yes
    Brand name
    LIORESAL
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      BACLOFEN
      Strength
      20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    LIORESAL
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      BACLOFEN
      Strength
      10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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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.