NDA 213973

DECIPHERA PHARMACEUTICALS LLC

FDA Drug Application

Application #213973

Documents

• Label: 2020-05-15
• Letter: 2020-05-19
• Review: 2020-06-17
• Label: 2021-06-22
• Letter: 2021-06-22
• Letter: 2022-09-16
• Label: 2022-09-19
• Letter: 2023-01-03
• Label: 2023-01-04

Application Sponsors

NDA 213973

DECIPHERA PHARMACEUTICALS LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG

2

QINLOCK

RIPRETINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-05-15	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2022-09-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-12-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	2

TE Codes

001

Prescription

TBD

CDER Filings

DECIPHERA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213973
            [companyName] => DECIPHERA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"QINLOCK","activeIngredients":"RIPRETINIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/15\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213973s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/15\/2020","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\\\/2020\\\/213973s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213973Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213973Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-15
        )

)