Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021986
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SPRYCEL | DASATINIB | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SPRYCEL | DASATINIB | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SPRYCEL | DASATINIB | 70MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SPRYCEL | DASATINIB | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| SPRYCEL | DASATINIB | 80MG | TABLET;ORAL | Prescription | AB | Yes | No |
| SPRYCEL | DASATINIB | 140MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/28/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021986s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021986_022072_SprycelTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/31/2024 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021986s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021986Orig1s028ltr.pdf | |
| 02/08/2023 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021986Orig1s027ltr.pdf | |
| 06/29/2021 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021986s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021986Orig1s025ltr.pdf | |
| 11/15/2018 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021986Orig1s023ltr.pdf | |
| 12/21/2018 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021986Orig1s021Ltr.pdf | |
| 11/09/2017 | SUPPL-20 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021986Orig1s020ltr.pdf | |
| 08/10/2017 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021986Orig1s019ltr.pdf | |
| 09/27/2016 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021986s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021986Orig1s018ltr.pdf | |
| 08/12/2015 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf | |
| 08/12/2015 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021986Orig1s016,s017ltr.pdf | |
| 01/26/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2014 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021986Orig1s014ltr.pdf | |
| 06/17/2013 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021986Orig1s013ltr.pdf | |
| 10/07/2011 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf | |
| 10/07/2011 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021986s009,s010ltr.pdf | |
| 10/28/2010 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s008ltr.pdf | |
| 10/28/2010 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021986s007ltr.pdf | |
| 07/28/2010 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022072s002,021986s005ltr.pdf | |
| 05/21/2009 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021986s004ltr.pdf | |
| 05/30/2008 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021986s003,022072s001ltr.pdf |
| 11/08/2007 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf | |
| 11/08/2007 | SUPPL-1 | Efficacy-New Dosing Regimen |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021986s001, 021986s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021986_s001_s002.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/31/2024 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021986s028lbl.pdf | |
| 02/08/2023 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf | |
| 06/29/2021 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021986s025lbl.pdf | |
| 12/21/2018 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf | |
| 11/15/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s023lbl.pdf | |
| 11/09/2017 | SUPPL-20 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s020lbl.pdf | |
| 08/10/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021986s019lbl.pdf | |
| 09/27/2016 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021986s018lbl.pdf | |
| 08/12/2015 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf | |
| 08/12/2015 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021986s016s017lbledt.pdf | |
| 04/10/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021986s014lbl.pdf | |
| 06/17/2013 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021986s013lbl.pdf | |
| 10/07/2011 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf | |
| 10/07/2011 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021986s009s010lbl.pdf | |
| 10/28/2010 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf | |
| 10/28/2010 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s7s8lbl.pdf | |
| 07/28/2010 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021986s005lbl.pdf | |
| 05/21/2009 | SUPPL-4 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021986s004lbl.pdf | |
| 11/08/2007 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021986s001s002lbl.pdf | |
| 06/28/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021986lbl.pdf |
SPRYCEL
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 20MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| SPRYCEL | DASATINIB | 20MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 50MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| SPRYCEL | DASATINIB | 50MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 70MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 70MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| SPRYCEL | DASATINIB | 70MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 100MG | TABLET;ORAL | Prescription | No | AB | 202103 | APOTEX |
| SPRYCEL | DASATINIB | 100MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 80MG | TABLET;ORAL | Prescription | No | AB | 203180 | APOTEX |
| SPRYCEL | DASATINIB | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 140MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DASATINIB | DASATINIB | 140MG | TABLET;ORAL | Prescription | No | AB | 203180 | APOTEX |
| SPRYCEL | DASATINIB | 140MG | TABLET;ORAL | Prescription | Yes | AB | 021986 | BRISTOL MYERS SQUIBB |