Approvals (Drugs@FDA)

GADOTERATE MEGLUMINE

VIWIT PHARM · GADOTERATE MEGLUMINE

ANDA219286Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219286
Sponsor name
VIWIT PHARM
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260810
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    GADOTERATE MEGLUMINE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      GADOTERATE MEGLUMINE
      Strength
      5.6535GM/15ML (376.9MG/ML)
  2. Product number
    003
    Reference drug
    No
    Brand name
    GADOTERATE MEGLUMINE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      GADOTERATE MEGLUMINE
      Strength
      7.538GM/20ML (376.9MG/ML)
  3. Product number
    001
    Reference drug
    No
    Brand name
    GADOTERATE MEGLUMINE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      GADOTERATE MEGLUMINE
      Strength
      3.769GM/10ML (376.9MG/ML)
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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.