ANDA 211212

AMNEAL PHARMS LLC

FDA Drug Application

Application #211212

Application Sponsors

ANDA 211212

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

SIROLIMUS

SIROLIMUS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211212
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)