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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205552
Company: PHARMACYCLICS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMBRUVICA IBRUTINIB 140MG CAPSULE;ORAL Prescription None Yes Yes
IMBRUVICA IBRUTINIB 70MG CAPSULE;ORAL Prescription None Yes 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
02/12/2014 ORIG-2 Approval Efficacy PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552Orig2s000SumR.pdf
11/13/2013 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205552Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205552Orig1S001.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205552Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2024 SUPPL-42 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s042,210563a018,217003s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205552Orig1s042; s018; s003ltr.pdf
05/18/2023 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205552s040,210563s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205552Orig1s040;210563Orig1s017ltr.pdf
08/24/2022 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s038,210563s014lbl.pdf
08/24/2022 SUPPL-37 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

08/24/2022 SUPPL-36 Efficacy-New Patient Population Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s036,210563s012lbl.pdf
05/11/2022 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s035,215063s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205552Orig1s035; 215063Orig1s011ltr.pdf
12/22/2020 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s033,210563s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s033, 210563Orig1s010ltr.pdf
12/18/2020 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s032,210563s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s032; 210563Orig1s009ltr.pdf
08/07/2020 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s031,210563s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s031,210563Orig1s007ltr.pdf
04/21/2020 SUPPL-30 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lblPI.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205552Orig1s030,210563Orig1s006ltr.pdf
11/21/2019 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s029,210563s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205552Orig1s029, 210563Orig1s004ltr.pdf
07/15/2019 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s028,210563s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205552Orig1s028, 210563Orig1s003ltr.pdf
01/25/2019 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s026,210563s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205552Orig1s026,210563Orig1s002Ltr.pdf
08/24/2018 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s025ltr.pdf
08/24/2018 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s024,210563Orig1s001ltr.pdf
12/20/2017 SUPPL-20 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s020ltr.pdf
07/10/2017 SUPPL-18 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205552Orig1s042; s018; s003ltr.pdf
08/02/2017 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/205552Origs1s017.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/205552Orig1s017SumR.pdf
01/18/2017 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s016ltr.pdf
06/27/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/06/2016 SUPPL-13 Efficacy-New Indication Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf
06/28/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s012ltr.pdf
04/13/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/06/2016 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s010,s013ltr.pdf
11/25/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/08/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/04/2016 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205552Orig1s007ltr.pdf
03/21/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/24/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/17/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/13/2015 SUPPL-3 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205552Orig1s042; s018; s003ltr.pdf
01/29/2015 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205552Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/205552Orig1s002.pdf
07/28/2014 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205552s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2024 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s042,210563a018,217003s003lbl.pdf
05/09/2024 SUPPL-42 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s042,210563a018,217003s003lbl.pdf
05/18/2023 SUPPL-40 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205552s040,210563s017lbl.pdf
08/24/2022 SUPPL-38 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s038,210563s014lbl.pdf
08/24/2022 SUPPL-36 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s036,210563s012lbl.pdf
05/11/2022 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205552s035,215063s011lbl.pdf
12/22/2020 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s033,210563s010lbl.pdf
12/18/2020 SUPPL-32 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s032,210563s009lbl.pdf
08/07/2020 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s031,210563s007lbl.pdf
04/21/2020 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lblPI.pdf
11/21/2019 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s029,210563s004lbl.pdf
07/15/2019 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s028,210563s003lbl.pdf
01/25/2019 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s026,210563s002lbl.pdf
08/24/2018 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s025lbl.pdf
08/24/2018 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205552s024lbl.pdf
12/20/2017 SUPPL-20 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s020lbl.pdf
08/02/2017 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s017lbl.pdf
01/18/2017 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s016lbl.pdf
06/28/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdf
05/06/2016 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf
05/06/2016 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s010s013lbl.pdf
03/04/2016 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552s007lbl.pdf
01/29/2015 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf
07/28/2014 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf
02/12/2014 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552Orig2lbl.pdf
11/13/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205552s000lbl.pdf
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