Approvals (Drugs@FDA)

IBRUTINIB

HETERO LABS LTD V · IBRUTINIB

ANDA211182Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211182
Sponsor name
HETERO LABS LTD V
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260908
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      81456
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211182Orig1s000TAltr.pdf
      Date
      20250306
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    IBRUTINIB
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      IBRUTINIB
      Strength
      140MG
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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.