NDA 213422

MC2 Therapeutics Ltd

FDA Drug Application

Application #213422

Documents

• Letter: 2020-07-21
• Label: 2020-07-22
• Review: 2020-11-16
• Review: 2021-12-01

Application Sponsors

NDA 213422

MC2 Therapeutics Ltd

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.005%/0.064%

0

WYNZORA

CALCIPOTRIENE/BETAMETHASONE DIPROPIONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2020-07-20

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MC2 Therapeutics Ltd

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213422
            [companyName] => MC2 Therapeutics Ltd
            [docInserts] => ["",""]
            [products] => [{"drugName":"WYNZORA","activeIngredients":"CALCIPOTRIENE\/BETAMETHASONE DIPROPIONATE","strength":"0.005%\/0.064%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213422Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-20
        )

)