Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022198
Company: KYOWA KIRIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SANCUSO GRANISETRON 3.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL 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
09/12/2008 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022198lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022198s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022198_sancuso_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2017 SUPPL-16 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022198s016lbl.pdf
09/18/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022198s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022198Orig1s012ltr.pdf
07/15/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/19/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/14/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/23/2011 SUPPL-5 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022198s005ltr.pdf
09/28/2015 SUPPL-3 Labeling-Patient Package Insert, Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022198Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/13/2017 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022198s016lbl.pdf
09/28/2015 SUPPL-3 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf
09/28/2015 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022198s003lbl.pdf
09/18/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022198s012lbl.pdf
09/23/2011 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf
09/23/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022198s005lbl.pdf
09/12/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022198lbl.pdf

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