Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761054
Company: SAMSUNG BIOEPIS CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENFLEXIS INFLIXIMAB-ABDA 100MG INJECTABLE;INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/21/2017 ORIG-1 Approval N/A Label
Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761054Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761054Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2019 SUPPL-9 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761054Orig1s009ltr.pdf
03/21/2019 SUPPL-4 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s004lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/26/2019 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s009lbl.pdf
03/21/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761054s004lbl.pdf
04/21/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000lbledt.pdf
04/21/2017 ORIG-1 Approval https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761054Orig1s000TOC.cfm

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