NDA 214783

KADMON PHARMA LLC

FDA Drug Application

Application #214783

Documents

• Letter: 2021-07-19
• Label: 2021-07-20
• Review: 2021-08-13

Application Sponsors

NDA 214783

KADMON PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

REZUROCK

BELUMOSUDIL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-07-16

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

KADMON PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214783
            [companyName] => KADMON PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REZUROCK","activeIngredients":"BELUMOSUDIL","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/16\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214783s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214783s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214783Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-07-16
        )

)