CISEN FDA Approval ANDA 213158

ANDA 213158

CISEN

FDA Drug Application

Application #213158

Application Sponsors

ANDA 213158CISEN

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM
002CAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASE0ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-09-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CISEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213158
            [companyName] => CISEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 20MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE MAGNESIUM","activeIngredients":"ESOMEPRAZOLE MAGNESIUM","strength":"EQ 40MG BASE","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-22
        )

)

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