Approvals (Drugs@FDA)

MUSE

VIATRIS · ALPROSTADIL

NDA020700Drug (NDA)Discontinued
Open FDA's page for this record
Application number
NDA020700
Sponsor name
VIATRIS
Submissions
  1. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    19980330
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    19970909
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    19961119
    Review priority
    PRIORITY
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
  4. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20020604
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  5. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    19980127
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  6. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    19970213
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  7. Submission type
    SUPPL
    Submission number
    32
    Submission status
    AP
    Submission status date
    20240517
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      78514
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020700Orig1s032ltr.pdf
      Date
      20240520
      Type
      Letter
    2. ID
      78516
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020700s032lbl.pdf
      Date
      20240520
      Type
      Label
  8. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    19980331
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  9. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    19970909
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  10. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    20020730
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  11. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    19970909
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  12. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    19980624
    Review priority
    PRIORITY
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  13. +1 more not shown
Products
  1. Product number
    003
    Reference drug
    Yes
    Brand name
    MUSE
    Reference standard
    No
    Dosage form
    SUPPOSITORY
    Route
    URETHRAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      ALPROSTADIL
      Strength
      0.5MG
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    MUSE
    Reference standard
    No
    Dosage form
    SUPPOSITORY
    Route
    URETHRAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      ALPROSTADIL
      Strength
      0.125MG
  3. Product number
    004
    Reference drug
    Yes
    Brand name
    MUSE
    Reference standard
    No
    Dosage form
    SUPPOSITORY
    Route
    URETHRAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      ALPROSTADIL
      Strength
      1MG
  4. Product number
    002
    Reference drug
    Yes
    Brand name
    MUSE
    Reference standard
    No
    Dosage form
    SUPPOSITORY
    Route
    URETHRAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      ALPROSTADIL
      Strength
      0.25MG
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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.