VERU INC FDA Approval NDA 215423

NDA 215423

VERU INC

FDA Drug Application

Application #215423

Documents

Label2021-12-13
Letter2021-12-15

Application Sponsors

NDA 215423VERU INC

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL5MG;5MG0ENTADFIFINASTERIDE;TADALAFIL

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2021-12-09STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

VERU INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215423
            [companyName] => VERU INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTADFI","activeIngredients":"FINASTERIDE;TADALAFIL","strength":"5MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/09\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215423s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215423s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-09
        )

)

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