MYLAN FDA Approval NDA 213691

NDA 213691

MYLAN

FDA Drug Application

Application #213691

Documents

Letter2020-05-20
Label2020-05-22

Application Sponsors

NDA 213691MYLAN

Marketing Status

Prescription001

Application Products

001LOTION;TOPICAL0.05% W/W0IMPEKLOCLOBETASOL PROPIONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2020-05-19STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213691
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMPEKLO","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05% W\/W","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/19\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213691s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213691s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213691Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-19
        )

)

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