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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761113
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SARCLISA ISATUXIMAB-IRFC 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription None No No
SARCLISA ISATUXIMAB-IRFC 500MG/25ML (20MG/ML) 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
03/02/2020 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761113Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761113Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2024 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761113Orig1s014ltr.pdf
10/25/2024 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761113Orig1s012ltr.pdf
10/25/2024 SUPPL-11 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761113Orig1s011ltr.pdf
11/01/2023 SUPPL-9 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761113s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761113Orig1s009ltr.pdf
07/15/2022 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761113s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761113Orig1s006ltr.pdf
03/18/2021 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761113Orig1s004ltr.pdf
03/31/2021 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761113Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2024 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s012lbl.pdf
10/25/2024 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s011lbl.pdf
09/20/2024 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s014lbl.pdf
11/01/2023 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761113s009lbl.pdf
07/15/2022 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761113s006lbl.pdf
03/31/2021 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s003lbl.pdf
03/18/2021 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s004lbl.pdf
03/18/2021 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s004lbl.pdf
03/02/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf
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