NDA 212099

BAYER HEALTHCARE

FDA Drug Application

Application #212099

Documents

• Label: 2019-07-31
• Letter: 2019-07-31
• Review: 2019-08-29
• Letter: 2021-01-08
• Label: 2021-01-08
• Letter: 2022-08-08
• Label: 2022-08-11

Application Sponsors

NDA 212099

BAYER HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG

1

NUBEQA

DAROLUTAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-07-30	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-08-05	PRIORITY

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

BAYER HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212099
            [companyName] => BAYER HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUBEQA","activeIngredients":"DAROLUTAMIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/30\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212099Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212099Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212099Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212099Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-07-30
        )

)