Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125409
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERJETA PERTUZUMAB 420MG/14ML 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
06/08/2012 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125409Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/22/2016 SUPPL-109 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125409Orig1s109ltr.pdf
05/29/2015 SUPPL-105 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s105ltr.pdf
03/17/2015 SUPPL-104 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s104ltr.pdf
09/30/2013 SUPPL-51 Supplement Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s051_corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409_perjeta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409Orig1s051SumR.pdf
04/12/2013 SUPPL-32 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s032ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/22/2016 SUPPL-109 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf
05/29/2015 SUPPL-105 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s105lbl.pdf
03/17/2015 SUPPL-104 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s104lbl.pdf
09/30/2013 SUPPL-51 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf
04/12/2013 SUPPL-32 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s032lbl.pdf
06/08/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf

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