NDA 216513

MEDUNIK CANADA INC.

FDA Drug Application

Application #216513

Documents

• Letter: 2022-06-21
• Label: 2022-06-21

Application Sponsors

NDA 216513

MEDUNIK CANADA INC.

Marketing Status

• Prescription: 001

Application Products

001

PELLETS;ORAL

84GM/BOT

1

PHEBURANE

SODIUM PHENYLBUTYRATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-06-17

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216513
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)