NDA 214133

STRONGBRIDGE DUBLIN LTD

FDA Drug Application

Application #214133

Documents

• Letter: 2022-01-03
• Label: 2022-07-15
• Medication Guide: 2022-07-15
• Review: 2022-10-05

Application Sponsors

NDA 214133

STRONGBRIDGE DUBLIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

150MG

0

RECORLEV

LEVOKETOCONAZOLE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient

ORIG

1

AP

2021-12-30

STANDARD

Submissions Property Types

ORIG

1

Null

40

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
        )

)