BAYER HEALTHCARE PHARMS FDA Approval NDA 215341

NDA 215341

BAYER HEALTHCARE PHARMS

FDA Drug Application

Application #215341

Documents

Label2021-07-12
Letter2021-07-12

Application Sponsors

NDA 215341BAYER HEALTHCARE PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET; ORAL10MG0KERENDIAFINERENONE
002TABLET; ORAL20MG0KERENDIAFINERENONE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-07-09PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

BAYER HEALTHCARE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215341
            [companyName] => BAYER HEALTHCARE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KERENDIA","activeIngredients":"FINERENONE","strength":"10MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"KERENDIA","activeIngredients":"FINERENONE","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/09\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215341s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/09\/2021","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\\\/2021\\\/215341s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215341Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-07-09
        )

)

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