STRONGBRIDGE DUBLIN LTD FDA Approval NDA 214133

NDA 214133

STRONGBRIDGE DUBLIN LTD

FDA Drug Application

Application #214133

Documents

Letter2022-01-03

Application Sponsors

NDA 214133STRONGBRIDGE DUBLIN LTD

Marketing Status

Prescription001

Application Products

001TABLET; ORAL150MG0RECORLEVLEVOKETOCONAZOLE

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2021-12-30STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

STRONGBRIDGE DUBLIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214133
            [companyName] => STRONGBRIDGE DUBLIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RECORLEV","activeIngredients":"LEVOKETOCONAZOLE","strength":"150MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214133Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-30
        )

)

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