NDA 214998

MYOKARDIA INC

FDA Drug Application

Application #214998

Documents

• Label: 2022-04-29
• Letter: 2022-05-02
• Review: 2022-06-10
• Letter: 2022-11-25
• Letter: 2023-01-17

Application Sponsors

NDA 214998

MYOKARDIA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE; ORAL	2.5MG	0	CAMZYOS	MAVACAMTEN
002	CAPSULE; ORAL	5MG	0	CAMZYOS	MAVACAMTEN
003	CAPSULE; ORAL	10MG	0	CAMZYOS	MAVACAMTEN
004	CAPSULE; ORAL	15MG	0	CAMZYOS	MAVACAMTEN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2022-04-28	STANDARD
REMS; REMS	SUPPL	3	AP	2022-11-22	N/A
REMS; REMS	SUPPL	4	AP	2023-01-13	N/A

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6

CDER Filings

Accessdata Error

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

)