ANDA 204923

AUROLIFE PHARMA LLC

FDA Drug Application

Application #204923

Application Sponsors

ANDA 204923

AUROLIFE PHARMA LLC

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

20MG;1.1GM

0

OMEPRAZOLE AND SODIUM BICARBONATE

OMEPRAZOLE; SODIUM BICARBONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-07

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204923
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-07
        )

)