Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125147
Company: AMGEN
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 |
---|---|---|---|---|---|
08/25/2021 | SUPPL-210 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125147Orig1s210ltr.pdf | |
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 |
---|---|---|---|---|---|
08/25/2021 | SUPPL-210 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125147s210lbl.pdf | |
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 |