Approvals (Drugs@FDA)

TIMOLOL MALEATE

AMNEAL · TIMOLOL MALEATE

ANDA216343Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA216343
Sponsor name
AMNEAL
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240523
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      78840
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216343Orig1s000ltr.pdf
      Date
      20240620
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250519
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    TIMOLOL MALEATE
    Reference standard
    No
    Dosage form
    SOLUTION, GEL FORMING/DROPS
    Route
    OPHTHALMIC
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      TIMOLOL MALEATE
      Strength
      EQ 0.5% BASE
  2. Product number
    001
    Reference drug
    No
    Brand name
    TIMOLOL MALEATE
    Reference standard
    No
    Dosage form
    SOLUTION, GEL FORMING/DROPS
    Route
    OPHTHALMIC
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      TIMOLOL MALEATE
      Strength
      EQ 0.25% BASE
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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.