NDA 214377

MERCK SHARP DOHME

FDA Drug Application

Application #214377

Documents

• Label: 2021-01-19
• Letter: 2021-01-21
• Review: 2021-02-17
• Letter: 2022-11-25
• Label: 2022-11-27

Application Sponsors

NDA 214377

MERCK SHARP DOHME

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	2.5MG	2	VERQUVO	VERICIGUAT
002	TABLET;ORAL	5MG	2	VERQUVO	VERICIGUAT
003	TABLET;ORAL	10MG	2	VERQUVO	VERICIGUAT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-01-19

PRIORITY

Submissions Property Types

ORIG

1

Null

7

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
        )

)