Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202570
Company: PF PRISM CV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XALKORI CRIZOTINIB 200MG CAPSULE;ORAL Prescription None Yes No
XALKORI CRIZOTINIB 250MG 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
08/26/2011 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/2011/202570s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202570s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2017 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s021ltr.pdf
01/24/2017 SUPPL-20 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s020ltr.pdf
04/28/2017 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202570Orig1s019ltr.pdf
04/28/2016 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s018ltr.pdf
04/29/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s017ltr.pdf
03/11/2016 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s016ltr.pdf
12/07/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/14/2015 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s014ltr.pdf
03/20/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s013ltr.pdf
08/26/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/28/2014 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202570s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202570Orig1s011ltr.pdf
02/14/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/07/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s007,s009ltr.pdf
09/13/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/07/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570s007,s009ltr.pdf
11/20/2013 SUPPL-6 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s006ltr.pdf
03/12/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/28/2013 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s004ltr.pdf
02/24/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s003ltr.pdf
02/17/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/21/2017 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s021lbl.pdf
04/28/2017 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s019lbl.pdf
01/24/2017 SUPPL-20 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202570s020lbl.pdf
04/29/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s017lbl.pdf
04/28/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s018lbl.pdf
03/11/2016 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf
09/14/2015 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s014lbl.pdf
03/20/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s013lbl.pdf
05/28/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202570s011lbl.pdf
11/20/2013 SUPPL-6 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s006lbl.pdf
10/07/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s009lbl.pdf
10/07/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s007lbl.pdf
02/28/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s004lbl.pdf
02/24/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf
02/17/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s002lbl.pdf
08/26/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf

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