Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021602
Company: MILLENNIUM PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VELCADE BORTEZOMIB 3.5MG/VIAL INJECTABLE;INTRAVENOUS, SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/13/2003 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21602ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21602_Velcade.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2019 SUPPL-44 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021602s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021602Orig1s044ltr.pdf
06/09/2017 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021602s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021602Orig1s043ltr.pdf
09/14/2015 SUPPL-42 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021602s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021602Orig1s042ltr.pdf
08/20/2015 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/08/2014 SUPPL-40 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s040ltr.pdf
09/08/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/08/2014 SUPPL-38 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021602Orig1s038ltr.pdf
03/13/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/05/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

08/02/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/01/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/26/2012 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602Orig1s031,s032ltr.pdf
10/26/2012 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602Orig1s031,s032ltr.pdf
11/01/2011 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021602s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021602s029,s030ltr.pdf
11/01/2011 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021602s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021602s029,s030ltr.pdf
04/07/2011 SUPPL-28 Labeling-Container/Carton Labels

Label is not available on this site.

01/23/2012 SUPPL-27 Efficacy-New Route Of Administration Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021602s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021602Orig1s027.pdf
12/03/2010 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021602s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021602s023ltr.pdf
12/30/2009 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s019s020ltr.pdf
12/30/2009 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s019s020ltr.pdf
04/24/2009 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s018ltr.pdf
06/20/2008 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021602s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021602se1-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021602Orig1s015.pdf
10/10/2007 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021602s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021602s013ltr.pdf
12/08/2006 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021602s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021602s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021602_s010_velcade.pdf
05/31/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021602s008,s009.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021602s008, s009LTR.pdf
12/08/2005 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021602s007ltr.pdf
03/25/2005 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021602s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21602s006ltr.pdf
05/25/2004 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21602slr004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/25/2019 SUPPL-44 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021602s044lbl.pdf
06/09/2017 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021602s043lbl.pdf
09/14/2015 SUPPL-42 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021602s042lbl.pdf
10/08/2014 SUPPL-40 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s040lbl.pdf
08/08/2014 SUPPL-38 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021602s038lbl.pdf
10/26/2012 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s031s032lbl.pdf
10/26/2012 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s031s032lbl.pdf
01/23/2012 SUPPL-27 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021602s027lbl.pdf
11/01/2011 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021602s029s030lbl.pdf
11/01/2011 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021602s029s030lbl.pdf
12/03/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021602s023lbl.pdf
12/30/2009 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf
12/30/2009 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021602s019s020lbl.pdf
06/20/2008 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021602s015lbl.pdf
10/10/2007 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021602s013lbl.pdf
12/08/2006 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021602s010lbl.pdf
05/31/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021602s008,s009.pdf
03/25/2005 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021602s006lbl.pdf
05/13/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021602lbl.pdf

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