NDA 213691

MYLAN

FDA Drug Application

Application #213691

Documents

• Letter: 2020-05-20
• Label: 2020-05-22
• Review: 2020-11-03

Application Sponsors

NDA 213691

MYLAN

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05% W/W

0

IMPEKLO

CLOBETASOL PROPIONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

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
        )

)