Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125147
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VECTIBIX PANITUMUMAB 5ML/100MG INJECTABLE; IV (INFUSION) Prescription None No No
VECTIBIX PANITUMUMAB 10ML/200MG INJECTABLE; IV (INFUSION) Prescription None No No
VECTIBIX PANITUMUMAB 20ML/400MG INJECTABLE; IV (INFUSION) 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
09/27/2006 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125147s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125147LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125147s0000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/2017 SUPPL-207 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125147s207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125147Orig1s207ltr.pdf
03/11/2015 SUPPL-200 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125147s200lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125147Orig1s200ltr.pdf
08/30/2014 SUPPL-194 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s194ltr.pdf
05/23/2014 SUPPL-186 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s186lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s186ltr.pdf
03/28/2013 SUPPL-169 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125147s169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125147Orig1s169ltr.pdf
08/17/2012 SUPPL-152 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125147Orig1s152ltr.pdf
08/17/2012 SUPPL-148 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125147s0148lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125147Orig1s0148ltr.pdf
12/12/2011 SUPPL-137 Supplement

Label is not available on this site.

03/15/2011 SUPPL-123 Supplement

Label is not available on this site.

05/23/2014 SUPPL-108 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125147Orig1s108ltr.pdf
05/26/2010 SUPPL-103 Supplement

Label is not available on this site.

07/17/2009 SUPPL-80 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s080lbl.pdf
07/17/2009 SUPPL-78 Supplement

Label is not available on this site.

04/27/2009 SUPPL-67 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125147s0067ltr.pdf
06/23/2008 SUPPL-26 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125147s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125147s026ltr.pdf
11/06/2007 SUPPL-18 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125147s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125147s018ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/29/2017 SUPPL-207 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125147s207lbl.pdf
03/11/2015 SUPPL-200 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125147s200lbl.pdf
08/30/2014 SUPPL-194 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s194lbl.pdf
05/23/2014 SUPPL-186 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s186lbl.pdf
05/23/2014 SUPPL-108 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125147s108lbl.pdf
03/28/2013 SUPPL-169 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125147s169lbl.pdf
08/17/2012 SUPPL-148 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125147s0148lbl.pdf
07/17/2009 SUPPL-80 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s080lbl.pdf
04/27/2009 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125147s067lbl.pdf
06/23/2008 SUPPL-26 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125147s026lbl.pdf
11/06/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125147s018lbl.pdf
09/27/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125147s0000lbl.pdf

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