HETERO LABS LTD III FDA Approval ANDA 203083

ANDA 203083

HETERO LABS LTD III

FDA Drug Application

Application #203083

Application Sponsors

ANDA 203083HETERO LABS LTD III

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED REL PELLETS;ORAL15MG0LANSOPRAZOLELANSOPRAZOLE
002CAPSULE, DELAYED REL PELLETS;ORAL30MG0LANSOPRAZOLELANSOPRAZOLE

FDA Submissions

UNKNOWN; ORIG1AP2020-05-18

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203083
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"15MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANSOPRAZOLE","activeIngredients":"LANSOPRAZOLE","strength":"30MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-18
        )

)

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