Approvals (Drugs@FDA)

OPUVIZ

SAMSUNG BIOEPIS CO LTD · AFLIBERCEPT-YSZY

BLA761350Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761350
Sponsor name
SAMSUNG BIOEPIS CO LTD
Submissions
  1. Submission type
    SUPPL
    Submission number
    9
    Submission status
    AP
    Submission status date
    20260319
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      85457
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761350Orig1s009ltr.pdf
      Date
      20260323
      Type
      Letter
    2. ID
      85503
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761350s009lbl.pdf
      Date
      20260324
      Type
      Label
  2. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20250825
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83201
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761350Orig1s007ltr.pdf
      Date
      20250826
      Type
      Letter
    2. ID
      83208
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761350s007lbl.pdf
      Date
      20250827
      Type
      Label
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240520
    Review priority
    STANDARD
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
    Application docs
    1. ID
      78513
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761350s000lbl.pdf
      Date
      20240520
      Type
      Label
    2. ID
      78521
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761350Orig1s000ltr.pdf
      Date
      20240520
      Type
      Letter
    3. ID
      79820
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761350Orig1s000TOC.html
      Date
      20241007
      Type
      Review
  4. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20250606
    Submission class code
    BIOSIMILAR
    Application docs
    1. ID
      82483
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761350s006lbl.pdf
      Date
      20250609
      Type
      Label
    2. ID
      82508
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761350Orig1s006ltr.pdf
      Date
      20250609
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    OPUVIZ
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      AFLIBERCEPT-YSZY
      Strength
      2MG(0.05ML,40MG/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.