NDA 215383

MERCK SHARP DOHME

FDA Drug Application

Application #215383

Documents

• Label: 2021-08-13
• Medication Guide: 2021-08-13
• Letter: 2021-08-16
• Review: 2021-09-10

Application Sponsors

NDA 215383

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

40MG

2

WELIREG

BELZUTIFAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-08-13

PRIORITY

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

TBD

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215383
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/215383s000lbl.pdf#page=14"]
            [products] => [{"drugName":"WELIREG","activeIngredients":"BELZUTIFAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"08\/13\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215383s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/13\/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\\\/215383s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215383Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-08-13
        )

)