Documents
Application Sponsors
NDA 215358 | NOVARTIS PHARMS CORP | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 20MG | 0 | SCEMBLIX | ASCIMINIB |
002 | TABLET;ORAL | 40MG | 0 | SCEMBLIX | ASCIMINIB |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-10-29 | PRIORITY |
TYPE 1; Type 1 - New Molecular Entity | ORIG | 2 | AP | 2021-10-29 | PRIORITY |
Submissions Property Types
TE Codes
001 | Prescription | TBD |
002 | Prescription | TBD |
CDER Filings
NOVARTIS PHARMS CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 215358
[companyName] => NOVARTIS PHARMS CORP
[docInserts] => ["",""]
[products] => [{"drugName":"SCEMBLIX","activeIngredients":"ASCIMINIB","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SCEMBLIX","activeIngredients":"ASCIMINIB","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/29\/2021","submission":"ORIG-2","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215358s000Orig2lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215358s000Orig1lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/29\/2021","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\\\/2021\\\/215358s000Orig2lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215358Orig2s000ltr.pdf\"}]","notes":">"},{"actionDate":"10\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215358s000Orig1lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215358Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-10-29
)
)