XIROMED FDA Approval ANDA 212977

ANDA 212977

XIROMED

FDA Drug Application

Application #212977

Application Sponsors

ANDA 212977XIROMED

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-12-10STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

XIROMED
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212977
            [companyName] => XIROMED
            [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":"12\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-10
        )

)

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