ANDA 213562

AMNEAL EU LTD

FDA Drug Application

Application #213562

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 213562

AMNEAL EU LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-11-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213562
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)