Approvals (Drugs@FDA)

YESAFILI

BIOCON BIOLOGICS INC · AFLIBERCEPT-JBVF

BLA761274Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA761274
Sponsor name
BIOCON BIOLOGICS INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240520
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      78512
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761274s000lbl.pdf
      Date
      20240520
      Type
      Label
    2. ID
      78520
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761274Orig1s000ltr.pdf
      Date
      20240520
      Type
      Letter
    3. ID
      80478
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761274Orig1s000TOC.html
      Date
      20241203
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260113
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      84754
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761274Orig1s001ltr.pdf
      Date
      20260115
      Type
      Letter
    2. ID
      84777
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761274s001lbl.pdf
      Date
      20260120
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20260820
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      87012
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761274Orig1s008ltr.pdf
      Date
      20260822
      Type
      Letter
    2. ID
      87027
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761274s008lbl.pdf
      Date
      20260825
      Type
      Label
  4. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20261022
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      87570
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761274s006lbl.pdf
      Date
      20261027
      Type
      Label
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    YESAFILI
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      AFLIBERCEPT-JBVF
      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.