Documents
Application Sponsors
| NDA 021986 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
Application Products
| 001 | TABLET;ORAL | 20MG | 1 | SPRYCEL | DASATINIB |
| 002 | TABLET;ORAL | 50MG | 1 | SPRYCEL | DASATINIB |
| 003 | TABLET;ORAL | 70MG | 1 | SPRYCEL | DASATINIB |
| 004 | TABLET;ORAL | 100MG | 1 | SPRYCEL | DASATINIB |
| 005 | TABLET;ORAL | 80MG | 1 | SPRYCEL | DASATINIB |
| 006 | TABLET;ORAL | 140MG | 1 | SPRYCEL | DASATINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2006-06-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2007-11-08 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2008-05-30 | N/A |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2009-05-21 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2010-07-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2010-10-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2010-10-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2011-10-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 10 | AP | 2011-10-07 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2013-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2014-04-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2015-01-26 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2015-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2015-08-12 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2016-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2017-08-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2017-11-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2018-12-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 2018-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2021-06-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 3 | Null | 4 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 15 | Null | 14 |
| SUPPL | 16 | Orphan | 5 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 25 | Orphan | 5 |
TE Codes
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 21986
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"SPRYCEL","activeIngredients":"DASATINIB","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SPRYCEL","activeIngredients":"DASATINIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SPRYCEL","activeIngredients":"DASATINIB","strength":"70MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SPRYCEL","activeIngredients":"DASATINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SPRYCEL","activeIngredients":"DASATINIB","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SPRYCEL","activeIngredients":"DASATINIB","strength":"140MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-21","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021986s021lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021986s023lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-20","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021986s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021986s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021986s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021986s016s017lbledt.pdf\"}]","notes":""},{"actionDate":"08\/12\/2015","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021986s016s017lbledt.pdf\"}]","notes":""},{"actionDate":"04\/10\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021986s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2013","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021986s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021986s009s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021986s009s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2010","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021986s7s8lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2010","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021986s7s8lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2010","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021986s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2009","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021986s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2007","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021986s001s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021986lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SPRYCEL","submission":"DASATINIB","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SPRYCEL","submission":"DASATINIB","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SPRYCEL","submission":"DASATINIB","actionType":"70MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SPRYCEL","submission":"DASATINIB","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SPRYCEL","submission":"DASATINIB","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SPRYCEL","submission":"DASATINIB","actionType":"140MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-21
)
)