AUROLIFE PHARMA LLC FDA Approval ANDA 204922

ANDA 204922

AUROLIFE PHARMA LLC

FDA Drug Application

Application #204922

Application Sponsors

ANDA 204922AUROLIFE PHARMA LLC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL20MG;1.1GM0OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE
002CAPSULE;ORAL40MG;1.1GM0OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2016-08-19

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AUROLIFE PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204922
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"20MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE AND SODIUM BICARBONATE","activeIngredients":"OMEPRAZOLE; SODIUM BICARBONATE","strength":"40MG;1.1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-19
        )

)

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