Approvals (Drugs@FDA)

MESALAMINE

AMNEAL · MESALAMINE

ANDA215067Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA215067
Sponsor name
AMNEAL
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250218
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20261015
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    MESALAMINE
    Reference standard
    No
    Dosage form
    TABLET, DELAYED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MESALAMINE
      Strength
      800MG
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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.