Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205755
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYKADIA CERITINIB 150MG 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
04/29/2014 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/2014/205755s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205755Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205755Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2017 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s012ltr.pdf
05/26/2017 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205755Orig1s009ltr.pdf
09/07/2016 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205755s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205755Orig1s006ltr.pdf
08/25/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/22/2015 SUPPL-4 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf
07/22/2015 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205755Orig1s003,s004ltr.pdf
06/24/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 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
07/19/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s012lbl.pdf
05/26/2017 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s009lbl.pdf
09/07/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205755s006lbl.pdf
07/22/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf
07/22/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf
07/22/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205755s003s004lbl.pdf
04/29/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205755s000lbl.pdf

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