NDA 211349

ASTELLAS

FDA Drug Application

Application #211349

Documents

• Label: 2018-11-28
• Letter: 2018-11-30
• Review: 2018-12-21
• Label: 2019-05-30
• Medication Guide: 2019-05-30
• Letter: 2019-06-04
• Review: 2020-09-14
• Letter: 2022-01-13
• Label: 2022-01-13
• Medication Guide: 2022-01-13

Application Sponsors

NDA 211349

ASTELLAS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 40MG BASE

1

XOSPATA

GILTERITINIB FUMARATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-11-28	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2022-01-12	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	3	Null	7

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211349
            [companyName] => ASTELLAS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/211349s001lbl.pdf#page=18"]
            [products] => [{"drugName":"XOSPATA","activeIngredients":"GILTERITINIB FUMARATE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/29\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211349s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/28\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211349s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/28\/2018","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\\\/2018\\\/211349s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211349Orig1s000replacementltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/211349Orig1_toc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/29\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211349s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211349Orig1s001ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211349Orig1s001.pdf\"}]","notes":">"}]
            [actionDate] => 2019-05-29
        )

)