Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205552
Company: PHARMACYCLICS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMBRUVICA IBRUTINIB 140MG 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
02/12/2014 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
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/2013/205552Orig1s000TOC.cfm 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
08/02/2017 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205552s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205552Orig1s017ltr.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)

Label is not available on this site.

01/29/2015 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205552s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205552Orig1s002ltr.pdf
07/28/2014 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205552s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205552Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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