Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022405
Company: GENZYME CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAPRELSA VANDETANIB 100MG TABLET;ORAL Prescription None Yes No
CAPRELSA VANDETANIB 300MG 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
04/06/2011 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/2011/022405s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2018 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022405s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022405Orig1s14ltr.pdf
02/24/2017 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

07/28/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022405s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022405Orig1s010ltr.pdf
05/16/2017 SUPPL-9 REMS - ASSESSMENT - MODIFIED Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022405Orig1s009ltr.pdf
03/31/2014 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022405Orig1s007ltr.pdf
11/27/2013 SUPPL-5 Labeling-Medication Guide Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s005ltr.pdf
07/03/2013 SUPPL-4 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s004ltr.pdf
10/09/2012 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022405Orig1s003ltr.pdf
06/22/2011 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/12/2018 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022405s014lbl.pdf
07/28/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022405s010lbl.pdf
03/31/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf
07/03/2013 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf
10/09/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf
10/09/2012 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf
06/22/2011 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s001lbl.pdf
04/06/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf

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