HETERO LABS LTD III FDA Approval ANDA 204012

ANDA 204012

HETERO LABS LTD III

FDA Drug Application

Application #204012

Application Sponsors

ANDA 204012HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED REL PELLETS;ORAL10MG0OMEPRAZOLEOMEPRAZOLE
002CAPSULE, DELAYED REL PELLETS;ORAL20MG0OMEPRAZOLEOMEPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2019-09-26
LABELING; LabelingSUPPL2AP2022-03-04STANDARD

Submissions Property Types

ORIG1Null17
SUPPL2Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204012
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"10MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OMEPRAZOLE","activeIngredients":"OMEPRAZOLE","strength":"20MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-26
        )

)

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