Documents
Application Sponsors
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 25MG | 1 | RYDAPT | MIDOSTAURIN |
FDA Submissions
| EFFICACY; Efficacy | ORIG | 1 | AP | 2017-04-28 | PRIORITY |
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 2 | AP | 2017-04-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-03-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2020-11-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-04-20 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-11-15 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| ORIG | 2 | Null | 6 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
CDER Filings
NOVARTIS
cder:Array
(
[0] => Array
(
[ApplNo] => 207997
[companyName] => NOVARTIS
[docInserts] => ["",""]
[products] => [{"drugName":"RYDAPT","activeIngredients":"MIDOSTAURIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/15\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207997s008lbledt.pdf\"}]","notes":""},{"actionDate":"04\/20\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207997s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207997s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207997s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207997s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2017","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207997Orig1Orig2s000lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207997s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/28\/2017","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207997Orig1Orig2s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207997Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/207997Orig1Orig2s000TOC.cfm\"}]","notes":">"},{"actionDate":"04\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207997s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207997Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"11\/15\/2021","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207997s008lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207997Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/20\/2021","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/207997s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/207997Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/24\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207997s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207997Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"03\/04\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207997s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207997Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"06\/21\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207997s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207997Orig1s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2021-11-15
)
)