NDA 213433

CASSIOPEA SPA

FDA Drug Application

Application #213433

Documents

• Letter: 2020-08-31
• Label: 2020-09-04
• Review: 2020-09-29
• Letter: 2022-03-21
• Label: 2022-04-05

Application Sponsors

NDA 213433

CASSIOPEA SPA

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1G

0

WINLEVI

CLASCOTERONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-08-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-03-18	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	15

CDER Filings

CASSIOPEA SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213433
            [companyName] => CASSIOPEA SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"WINLEVI","activeIngredients":"CLASCOTERONE","strength":"1G","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213433Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-26
        )

)