Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021660
Company: BRISTOL-MYERS
Company: BRISTOL-MYERS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABRAXANE | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/07/2005 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021660ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21660_AbraxaneTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/25/2020 | SUPPL-47 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021660s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021660Orig1s047ltr.pdf | |
| 12/06/2019 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021660s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021660Orig1s046ltr.pdf | |
| 08/16/2018 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021660s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021660Orig1s045Ltr.pdf | |
| 03/24/2016 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2015 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/2015 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021660Orig1s041ltr.pdf | |
| 12/11/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021660s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021660Orig1s040ltr.pdf | |
| 04/28/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s038ltr.pdf | |
| 09/06/2013 | SUPPL-37 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021660Orig1s037.pdf | |
| 06/07/2013 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s036ltr.pdf | |
| 09/28/2012 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf | |
| 09/28/2012 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf | |
| 12/10/2012 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/2012 | SUPPL-31 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021660Orig1s031.pdf | |
| 12/23/2011 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021660Orig1s029.pdf | |
| 12/23/2011 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021660Orig1s026.pdf | |
| 12/23/2011 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021660Orig1s025.pdf | |
| 06/26/2009 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021660s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021660s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021660Orig1s022.pdf | |
| 07/01/2008 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021660s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021660s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021660Orig1s013.pdf | |
| 02/15/2007 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021660s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021660s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021660Orig1s010.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/25/2020 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021660s047lbl.pdf | |
| 08/25/2020 | SUPPL-47 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021660s047lbl.pdf | |
| 12/06/2019 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021660s046lbl.pdf | |
| 08/16/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021660s045lbl.pdf | |
| 07/21/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf | |
| 12/11/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021660s040lbl.pdf | |
| 10/30/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s038lbl.pdf | |
| 09/06/2013 | SUPPL-37 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf | |
| 06/07/2013 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s036lbl.pdf | |
| 10/11/2012 | SUPPL-31 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s031lbl.pdf | |
| 09/28/2012 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf | |
| 09/28/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf | |
| 12/23/2011 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf | |
| 12/23/2011 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf | |
| 12/23/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf | |
| 06/26/2009 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021660s022lbl.pdf | |
| 07/01/2008 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021660s013lbl.pdf | |
| 02/15/2007 | SUPPL-10 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021660s010lbl.pdf | |
| 01/07/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf |
ABRAXANE
POWDER;INTRAVENOUS; 100MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABRAXANE | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AB | 021660 | BRISTOL-MYERS |
| PACLITAXEL | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AB | 211875 | AM REGENT |
| PACLITAXEL | PACLITAXEL | 100MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AB | 216338 | TEVA PHARMS INC |