NDA 215309

INCYTE CORP

FDA Drug Application

Application #215309

Documents

• Letter: 2021-09-22
• Review: 2022-07-06
• Label: 2022-07-14
• Letter: 2022-07-19
• Label: 2022-07-19
• Medication Guide: 2022-07-19

Application Sponsors

NDA 215309

INCYTE CORP

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

OPZELURA

RUXOLITINIB

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated

ORIG

1

AP

2021-09-21

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

INCYTE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215309
            [companyName] => INCYTE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"OPZELURA","activeIngredients":"RUXOLITINIB","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215309Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-21
        )

)