MERCK SHARP DOHME FDA Approval NDA 214377

NDA 214377

MERCK SHARP DOHME

FDA Drug Application

Application #214377

Documents

Label2021-01-19
Letter2021-01-21
Review2021-02-17

Application Sponsors

NDA 214377MERCK SHARP DOHME

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG2VERQUVOVERICIGUAT
002TABLET;ORAL5MG2VERQUVOVERICIGUAT
003TABLET;ORAL10MG2VERQUVOVERICIGUAT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-01-19PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214377
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERQUVO","activeIngredients":"VERICIGUAT","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"VERQUVO","activeIngredients":"VERICIGUAT","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"VERQUVO","activeIngredients":"VERICIGUAT","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/19\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214377s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214377s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214377Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-01-19
        )

)

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