Approvals (Drugs@FDA)

CRISABOROLE

MACLEODS PHARMS · CRISABOROLE

ANDA216242Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA216242
Sponsor name
MACLEODS PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260924
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CRISABOROLE
    Reference standard
    No
    Dosage form
    OINTMENT
    Route
    TOPICAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      CRISABOROLE
      Strength
      2%
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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.