Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE;ORAL | EQ 200MG BASE | 1 | TASIGNA | NILOTINIB HYDROCHLORIDE |
| 002 | CAPSULE;ORAL | EQ 150MG BASE | 1 | TASIGNA | NILOTINIB HYDROCHLORIDE |
| 003 | CAPSULE;ORAL | EQ 50MG BASE | 1 | TASIGNA | NILOTINIB HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2007-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2009-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2010-06-17 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2010-06-17 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2011-01-14 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-10-26 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2011-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2011-11-18 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2012-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2012-05-01 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2013-05-17 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2013-06-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2013-08-14 | STANDARD |
| REMS; REMS | SUPPL | 16 | AP | 2013-05-22 | N/A |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2014-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-09-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 19 | AP | 2014-09-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2015-01-27 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2015-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2016-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-02-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2017-12-22 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 27 | AP | 2018-03-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 2018-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2019-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2020-12-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 35 | AP | 2021-09-23 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2021-09-23 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 13 | Null | 14 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 14 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Orphan | 5 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 26 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 6 |
CDER Filings
NOVARTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 22068
[companyName] => NOVARTIS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/022068s035s036lbl.pdf#page=36"]
[products] => [{"drugName":"TASIGNA","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TASIGNA","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"TASIGNA","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"09\/23\/2021","submission":"SUPPL-36","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022068s035s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2021","submission":"SUPPL-35","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022068s035s036lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2020","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022068s033lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2019","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022068s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022068s029lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2018","submission":"SUPPL-27","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022068s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2017","submission":"SUPPL-26","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022068s026lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2017","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022068s024lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022068s023lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022068s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2015","submission":"SUPPL-20","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022068s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022068s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2014","submission":"SUPPL-17","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022068s017lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022068s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2013","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022068s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022068s014lbledt.pdf\"}]","notes":""},{"actionDate":"12\/20\/2012","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022068s011lbledt2.pdf\"}]","notes":""},{"actionDate":"05\/01\/2012","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022068s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022068s008s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022068s008s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022068s008s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022068s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/14\/2011","submission":"SUPPL-6","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022068s006lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2010","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022068s004s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022068s004s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2010","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022068s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2010","submission":"SUPPL-1","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022068s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022068s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022068lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TASIGNA","submission":"NILOTINIB HYDROCHLORIDE","actionType":"EQ 200MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TASIGNA","submission":"NILOTINIB HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TASIGNA","submission":"NILOTINIB HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-09-23
)
)