Approvals (Drugs@FDA)

BREXPIPRAZOLE

APOTEX · BREXPIPRAZOLE

ANDA213731Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA213731
Sponsor name
APOTEX
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250224
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      77367
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213731Orig1s000TA_ltr.pdf
      Date
      20240131
      Type
      Letter
Products
  1. Product number
    005
    Reference drug
    No
    Brand name
    BREXPIPRAZOLE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      BREXPIPRAZOLE
      Strength
      3MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    BREXPIPRAZOLE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      BREXPIPRAZOLE
      Strength
      1MG
  3. Product number
    001
    Reference drug
    No
    Brand name
    BREXPIPRAZOLE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      BREXPIPRAZOLE
      Strength
      0.25MG
  4. Product number
    004
    Reference drug
    No
    Brand name
    BREXPIPRAZOLE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      BREXPIPRAZOLE
      Strength
      2MG
  5. Product number
    002
    Reference drug
    No
    Brand name
    BREXPIPRAZOLE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      BREXPIPRAZOLE
      Strength
      0.5MG
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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.