Approvals (Drugs@FDA)

LANREOTIDE ACETATE

AMNEAL · LANREOTIDE ACETATE

ANDA218217Generic (ANDA)Prescription
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Application number
ANDA218217
Sponsor name
AMNEAL
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
    001
    Reference drug
    No
    Brand name
    LANREOTIDE ACETATE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LANREOTIDE ACETATE
      Strength
      EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
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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.