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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125557
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BLINCYTO BLINATUMOMAB 35MCG 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
12/03/2014 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125557Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/08/2024 SUPPL-29 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125557Orig1s029ltr.pdf
06/14/2024 SUPPL-28 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125557Orig1s028Correctedltr.pdf
06/20/2023 SUPPL-26 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125557Orig1s023,s026ltr.pdf
12/05/2022 SUPPL-25 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125557Orig1s025ltr.pdf
06/20/2023 SUPPL-23 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125557Orig1s023,s026ltr.pdf
02/18/2022 SUPPL-21 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125557Orig1s021ltr.pdf
03/11/2021 SUPPL-20 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125557Orig1s020ltr.pdf
03/11/2021 SUPPL-19 Supplement

Label is not available on this site.

03/11/2021 SUPPL-18 Supplement

Label is not available on this site.

03/20/2020 SUPPL-17 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125557Orig1s017ltr.pdf
04/18/2019 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf
04/18/2019 SUPPL-15 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf
04/10/2018 SUPPL-14 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s014ltr.pdf
03/29/2018 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125557Orig1s013.pdf
11/30/2017 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s012ltr.pdf
07/11/2017 SUPPL-8 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s008ltr.pdf
05/03/2017 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125557Orig1s007.pdf
08/30/2016 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf
08/30/2016 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125557Orig1s005TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/14/2024 SUPPL-28 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf
02/08/2024 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557s029lbl.pdf
06/20/2023 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf
06/20/2023 SUPPL-23 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf
02/18/2022 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf
03/11/2021 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf
03/20/2020 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf
04/18/2019 SUPPL-16 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf
04/18/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf
03/29/2018 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf
11/30/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf
07/11/2017 SUPPL-8 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf
05/03/2017 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf
05/03/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf
08/30/2016 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
08/30/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
08/30/2016 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
12/03/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf
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