Approvals (Drugs@FDA)

SEMAGLUTIDE

APOTEX INC · SEMAGLUTIDE

ANDA220314Generic (ANDA)None (Tentative Approval)
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Application number
ANDA220314
Sponsor name
APOTEX INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    TA
    Submission status date
    20260407
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    SEMAGLUTIDE
    Reference standard
    No
    Dosage form
    INJECTION
    Route
    SOLUTION
    Marketing status
    None (Tentative Approval)
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      8MG/3ML
  2. Product number
    001
    Reference drug
    No
    Brand name
    SEMAGLUTIDE
    Reference standard
    No
    Dosage form
    INJECTION
    Route
    SOLUTION
    Marketing status
    None (Tentative Approval)
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      2MG/3ML
  3. Product number
    002
    Reference drug
    No
    Brand name
    SEMAGLUTIDE
    Reference standard
    No
    Dosage form
    INJECTION
    Route
    SOLUTION
    Marketing status
    None (Tentative Approval)
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      4MG/3ML
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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.