ANDA 212894

AMNEAL PHARMS LLC

FDA Drug Application

Application #212894

Application Sponsors

ANDA 212894

AMNEAL PHARMS LLC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;ORAL

1MG/ML

0

ENALAPRIL MALEATE

ENALAPRIL MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-10-25

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212894
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRIL MAQLEATE","activeIngredients":"ENALAPRIL MAQLEATE","strength":"1MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/25\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-25
        )

)