MYOKARDIA INC FDA Approval NDA 214998

NDA 214998

MYOKARDIA INC

FDA Drug Application

Application #214998

Documents

Label2022-04-29
Letter2022-05-02

Application Sponsors

NDA 214998MYOKARDIA INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE; ORAL2.5MG0CAMZYOSMAVACAMTEN
002CAPSULE; ORAL5MG0CAMZYOSMAVACAMTEN
003CAPSULE; ORAL10MG0CAMZYOSMAVACAMTEN
004CAPSULE; ORAL15MG0CAMZYOSMAVACAMTEN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-04-28STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214998
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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