Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210563
Company: PHARMACYCLICS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMBRUVICA IBRUTINIB 140MG TABLET;ORAL Prescription None Yes No
IMBRUVICA IBRUTINIB 280MG TABLET;ORAL Prescription None Yes No
IMBRUVICA IBRUTINIB 420MG TABLET;ORAL Prescription None Yes No
IMBRUVICA IBRUTINIB 560MG TABLET;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
02/16/2018 ORIG-2 Approval Efficacy PRIORITY; Orphan Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563-orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210563Orig1s000,210563Orig2s000TOC.cfm
02/16/2018 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210563Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210563Orig1s000,210563Orig2s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2020 SUPPL-10 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,%20210563Orig1s010ltr.pdf
12/18/2020 SUPPL-9 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-7 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-6 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-4 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-3 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-2 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-1 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205552Orig1s024,210563Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/22/2020 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s033,210563s010lbl.pdf
12/18/2020 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s032,210563s009lbl.pdf
08/07/2020 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s031,210563s007lbl.pdf
04/21/2020 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205552s030,210563s006lblPI.pdf
11/21/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s029,210563s004lbl.pdf
07/15/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s028,210563s003lbl.pdf
01/25/2019 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205552s026,210563s002lbl.pdf
08/24/2018 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s001lbl.pdf
02/16/2018 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563-orig2lbl.pdf
02/16/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563s000lbl.pdf

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