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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761174
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JEMPERLI DOSTARLIMAB-GXLY 500MG/10ML 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
04/22/2021 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761174s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761174Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761174Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2023 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761174Orig1s006ltr.pdf
02/09/2023 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761174Orig1s003,s004ltr.pdf
02/09/2023 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761174Orig1s003,s004ltr.pdf
04/28/2022 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761174Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2023 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s006lbl.pdf
02/09/2023 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf
02/09/2023 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf
04/28/2022 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf
04/22/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761174s000lbl.pdf
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