Approvals (Drugs@FDA)

EVEROLIMUS

NOVITIUM PHARMA · EVEROLIMUS

ANDA220597Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220597
Sponsor name
NOVITIUM PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260921
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    EVEROLIMUS
    Reference standard
    No
    Dosage form
    TABLET, FOR SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      EVEROLIMUS
      Strength
      3MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    EVEROLIMUS
    Reference standard
    No
    Dosage form
    TABLET, FOR SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      EVEROLIMUS
      Strength
      5MG
  3. Product number
    001
    Reference drug
    No
    Brand name
    EVEROLIMUS
    Reference standard
    No
    Dosage form
    TABLET, FOR SUSPENSION
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      EVEROLIMUS
      Strength
      2MG
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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.