NDA 215358

NOVARTIS PHARMS CORP

FDA Drug Application

Application #215358

Documents

• Label: 2021-10-29
• Label: 2021-10-29
• Letter: 2021-11-01
• Letter: 2021-11-01
• Review: 2021-11-24
• Review: 2021-11-24
• Letter: 2022-10-13
• Label: 2022-10-13

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

ORIG	1	Null	30
ORIG	2	Null	2

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
        )

)