ANDA 211405

AMNEAL PHARMS

FDA Drug Application

Application #211405

Application Sponsors

ANDA 211405

AMNEAL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

EQ 400MG BASE

0

QUETIAPINE FUMARATE

QUETIAPINE FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211405
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUETIAPINE FUMARATE","activeIngredients":"QUETIAPINE FUMARATE","strength":"EQ 400MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-26
        )

)