Approvals (Drugs@FDA)

BETAGAN

ALLERGAN · LEVOBUNOLOL HYDROCHLORIDE

NDA019219Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA019219
Sponsor name
ALLERGAN
Submissions
  1. Submission type
    SUPPL
    Submission number
    16
    Submission status
    AP
    Submission status date
    19980501
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  2. Submission type
    SUPPL
    Submission number
    22
    Submission status
    AP
    Submission status date
    20011204
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  3. Submission type
    SUPPL
    Submission number
    14
    Submission status
    AP
    Submission status date
    19950612
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  4. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    19851219
    Review priority
    STANDARD
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      57629
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019219Orig1s000rev.pdf
      Date
      20190215
      Type
      Review
  5. Submission type
    SUPPL
    Submission number
    20
    Submission status
    AP
    Submission status date
    20010808
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      11454
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf
      Date
      20030415
      Type
      Label
  6. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    19940113
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  7. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    19900131
    Submission class code
    LABELING
    Submission class code description
    Labeling
  8. Submission type
    SUPPL
    Submission number
    29
    Submission status
    AP
    Submission status date
    20171222
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      50912
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019219Orig1s029ltr.pdf
      Date
      20171227
      Type
      Letter
    2. ID
      50931
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019219s029lbl.pdf
      Date
      20171227
      Type
      Label
  9. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    19881021
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  10. Submission type
    SUPPL
    Submission number
    19
    Submission status
    AP
    Submission status date
    20010514
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  11. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    19870915
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  12. Submission type
    SUPPL
    Submission number
    17
    Submission status
    AP
    Submission status date
    19980519
    Review priority
    STANDARD
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  13. +11 more not shown
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    BETAGAN
    Reference standard
    Yes
    Dosage form
    SOLUTION/DROPS
    Route
    OPHTHALMIC
    Marketing status
    Prescription
    Te code
    AT
    Active ingredients
    1. Name
      LEVOBUNOLOL HYDROCHLORIDE
      Strength
      0.5%
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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.