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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206947
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LENVIMA LENVATINIB MESYLATE EQ 4MG BASE CAPSULE;ORAL Prescription None Yes No
LENVIMA LENVATINIB MESYLATE EQ 10MG BASE CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/2015 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206947Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2024 SUPPL-31 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206947s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206947Orig1s031ltr.pdf
04/03/2024 SUPPL-30 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206947s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206947Orig1s030ltr.pdf
10/23/2023 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206947s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206947Orig1s028ltr.pdf
08/05/2022 SUPPL-25 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206947Orig1s025ltr.pdf
11/10/2022 SUPPL-24 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206947Orig1s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/206947Orig1s024.pdf
12/19/2021 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206947Orig1s021ltr.pdf
07/21/2021 SUPPL-20 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206947s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206947Orig1s020ltr.pdf
08/10/2021 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206947Orig1s019ltr.pdf
12/18/2020 SUPPL-18 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s018ltr.pdf
09/14/2020 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s017ltr.pdf
11/10/2020 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s016ltr.pdf
04/23/2020 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s013ltr.pdf
02/20/2020 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s012ltr.pdf
09/17/2019 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206947s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206947Orig1s011ltr.pdf
12/07/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947Orig1s009Ltr.pdf
06/06/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206947Orig1s008ltr.pdf
08/15/2018 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206947Orig1s007ltr.pdf
07/31/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206947s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206947Orig1s005ltr.pdf
04/22/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s004ltr.pdf
05/13/2016 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s003ltr.pdf
10/16/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2024 SUPPL-31 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206947s031lbl.pdf
04/03/2024 SUPPL-30 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206947s030lbl.pdf
10/23/2023 SUPPL-28 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206947s028lbl.pdf
11/10/2022 SUPPL-24 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s024lbl.pdf
11/10/2022 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s024lbl.pdf
08/05/2022 SUPPL-25 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s025lbl.pdf
08/05/2022 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s025lbl.pdf
12/19/2021 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s021lbl.pdf
08/10/2021 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s019lbl.pdf
07/21/2021 SUPPL-20 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206947s020lbl.pdf
12/18/2020 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s018lbl.pdf
12/18/2020 SUPPL-18 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s018lbl.pdf
11/10/2020 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s016lbl.pdf
09/14/2020 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s017lbl.pdf
04/23/2020 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s013lbl.pdf
02/20/2020 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s012lbl.pdf
09/17/2019 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206947s011lbl.pdf
12/07/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s009lbl.pdf
08/15/2018 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s007lbl.pdf
06/06/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s008lbl.pdf
07/31/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206947s005lbl.pdf
05/13/2016 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s003lbl.pdf
04/22/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s004lbl.pdf
02/13/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf
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