Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125427
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KADCYLA ADO-TRASTUZUMAB EMTANSINE 100MG VIAL; SINGLE-USE Prescription None No No
KADCYLA ADO-TRASTUZUMAB EMTANSINE 160MG VIAL; SINGLE-USE Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/22/2013 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2016 SUPPL-96 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s096ltr.pdf
04/28/2016 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s094lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s094ltr.pdf
05/29/2015 SUPPL-87 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125427s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125427Orig1s087ltr.pdf
07/11/2014 SUPPL-33 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125427s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125427Orig1s033ltr.pdf
08/29/2013 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427Orig1s014Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s014ltr.pdf
08/19/2013 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s012ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2016 SUPPL-96 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s096lbl.pdf
04/28/2016 SUPPL-94 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s094lbledt.pdf
05/29/2015 SUPPL-87 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125427s087lbl.pdf
07/11/2014 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125427s033lbl.pdf
08/29/2013 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427Orig1s014Lbl.pdf
08/19/2013 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427s012lbl.pdf
02/22/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf

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