Approvals (Drugs@FDA)

LORATADINE

CATALENT PHARMA · LORATADINE

ANDA215127Generic (ANDA)Discontinued
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Application number
ANDA215127
Sponsor name
CATALENT PHARMA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250228
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    LORATADINE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      LORATADINE
      Strength
      10MG
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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.