NDA 215272

DERMAVANT SCIENCES INC

FDA Drug Application

Application #215272

Documents

• Letter: 2022-05-24
• Label: 2022-05-24
• Review: 2022-06-21

Application Sponsors

NDA 215272

DERMAVANT SCIENCES INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

2

VTAMA

TAPINAROF

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-05-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

DERMAVANT SCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215272
            [companyName] => DERMAVANT SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VTAMA","activeIngredients":"TAPINAROF","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/23\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215272s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215272s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215272Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-05-23
        )

)