Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021602
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VELCADE | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|
| 11/04/2021 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021602s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021602Orig1s046ltr.pdf | |
| 10/25/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021602s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021602Orig1s045ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 11/04/2021 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021602s046lbl.pdf | |
| 10/25/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021602s045lbl.pdf | |
| 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 |
VELCADE
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS; 3.5MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 205533 | APOTEX |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 213823 | BAXTER HLTHCARE CORP |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 202963 | DR REDDYS |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212825 | EUGIA PHARMA |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209659 | FRESENIUS KABI USA |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 208460 | HOSPIRA |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 215011 | JIANGSU HANSOH PHARM |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 212958 | MEITHEAL |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 209622 | MSN |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 208392 | PHARMASCIENCE INC |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 210824 | QILU PHARM HAINAN |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 203654 | SANDOZ |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 211898 | WAVERLEY PHARMA INC |
| BORTEZOMIB | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 210204 | ZYDUS PHARMS |
| VELCADE | BORTEZOMIB | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AP | 021602 | TAKEDA PHARMS USA |