Approvals (Drugs@FDA)

DEFLAZACORT

HIKMA · DEFLAZACORT

ANDA220524Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220524
Sponsor name
HIKMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260918
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    DEFLAZACORT
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DEFLAZACORT
      Strength
      30MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    DEFLAZACORT
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DEFLAZACORT
      Strength
      6MG
  3. Product number
    004
    Reference drug
    No
    Brand name
    DEFLAZACORT
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DEFLAZACORT
      Strength
      36MG
  4. Product number
    002
    Reference drug
    No
    Brand name
    DEFLAZACORT
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DEFLAZACORT
      Strength
      18MG
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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.