Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125084
Company: IMCLONE
Company: IMCLONE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERBITUX | CETUXIMAB | 100mg/VIAL | VIAL; INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 02/12/2004 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125084_erbitux_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/06/2021 | SUPPL-280 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s277s280lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125084Orig1s277, s280ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125084Orig1s277,s280.pdf | |
| 09/24/2021 | SUPPL-279 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125084Orig1s279ltr.pdf | |
| 04/06/2021 | SUPPL-277 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s277s280lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125084Orig1s277, s280ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125084Orig1s277,s280.pdf | |
| 11/10/2020 | SUPPL-275 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125084s275lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125084Orig1s275ltr.pdf | |
| 04/23/2019 | SUPPL-273 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125084s273lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125084Orig1s273ltr.pdf | |
| 06/05/2018 | SUPPL-269 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125084s269lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125084Orig1s269ltr.pdf | |
| 05/04/2018 | SUPPL-268 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125084Orig1s268lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125084Orig1s268ltr.pdf | |
| 10/11/2016 | SUPPL-265 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125084s265lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125084Orig1s265ltr.pdf | |
| 03/11/2015 | SUPPL-263 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s263ltr.pdf | |
| 04/10/2015 | SUPPL-262 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s262lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125084Orig1s262ltr.pdf | |
| 03/04/2013 | SUPPL-242 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125084s242lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125084Orig1s242ltr.pdf | |
| 01/19/2012 | SUPPL-229 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s229lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s229ltr.pdf | |
| 01/24/2012 | SUPPL-228 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s0228lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s228ltr.pdf | |
| 07/06/2012 | SUPPL-225 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125084s225ltr.pdf | |
| 03/24/2011 | SUPPL-203 | Supplement |
Label is not available on this site. |
||
| 07/08/2010 | SUPPL-193 | Supplement |
Label is not available on this site. |
||
| 07/17/2009 | SUPPL-168 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s168lbl.pdf | |
| 07/17/2009 | SUPPL-167 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125084s0167ltr.pdf | |
| 11/07/2011 | SUPPL-153 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125084s153lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125084s153ltr.pdf | |
| 09/12/2008 | SUPPL-139 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125084s139ltr.pdf |
| 11/20/2007 | SUPPL-112 | Supplement |
Label is not available on this site. |
||
| 10/02/2007 | SUPPL-103 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125084s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125084s103ltl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2007/125084Orig1s103.pdf | |
| 03/01/2006 | SUPPL-76 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046, 125084s076, 125084s077LTR.pdf | |
| 03/01/2006 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046LTR.pdf | |
| 09/01/2005 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125084_0030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125084_0030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/0125084_s030_erbitux.pdf | |
| 06/18/2004 | SUPPL-1 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125084-0001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/24/2021 | SUPPL-279 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf | |
| 04/06/2021 | SUPPL-280 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s277s280lbl.pdf | |
| 04/06/2021 | SUPPL-277 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s277s280lbl.pdf | |
| 11/10/2020 | SUPPL-275 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125084s275lbl.pdf | |
| 04/23/2019 | SUPPL-273 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125084s273lbl.pdf | |
| 06/05/2018 | SUPPL-269 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125084s269lbl.pdf | |
| 05/04/2018 | SUPPL-268 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125084Orig1s268lbl.pdf | |
| 10/11/2016 | SUPPL-265 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125084s265lbl.pdf | |
| 04/10/2015 | SUPPL-262 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s262lbl.pdf | |
| 03/11/2015 | SUPPL-263 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125084s063lbl.pdf | |
| 03/04/2013 | SUPPL-242 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125084s242lbl.pdf | |
| 07/06/2012 | SUPPL-225 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s225lbl.pdf | |
| 01/24/2012 | SUPPL-228 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s0228lbl.pdf | |
| 01/19/2012 | SUPPL-229 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125084s229lbl.pdf | |
| 11/07/2011 | SUPPL-153 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125084s153lbl.pdf | |
| 07/17/2009 | SUPPL-168 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s168lbl.pdf | |
| 07/17/2009 | SUPPL-167 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125084s167lbl.pdf | |
| 10/02/2007 | SUPPL-103 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125084s103lbl.pdf | |
| 03/01/2006 | SUPPL-76 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf | |
| 03/01/2006 | SUPPL-46 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125084s046LBL.pdf | |
| 09/01/2005 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125084_0030lbl.pdf | |
| 02/12/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125084lbl.pdf |