Documents
Application Sponsors
NDA 215341 | BAYER HEALTHCARE PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET; ORAL | 10MG | 0 | KERENDIA | FINERENONE |
002 | TABLET; ORAL | 20MG | 0 | KERENDIA | FINERENONE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-07-09 | PRIORITY |
Submissions Property Types
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
)
)