NDA 215985

ARCUTIS BIOTHERAPEUTICS, INC.

FDA Drug Application

Application #215985

Documents

• Letter: 2022-08-01
• Label: 2022-08-01
• Review: 2022-12-15

Application Sponsors

NDA 215985

ARCUTIS BIOTHERAPEUTICS, INC.

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.3%

0

ZORYVE

ROFUMILAST

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-07-29

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

ARCUTIS BIOTHERAPEUTICS, INC.

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(
    [0] => Array
        (
            [ApplNo] => 215985
            [companyName] => ARCUTIS BIOTHERAPEUTICS, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZORYVE","activeIngredients":"ROFUMILAST","strength":"0.3%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/29\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215985s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215985s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215985Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-07-29
        )

)