GLAND PHARMA LTD FDA Approval ANDA 203349

ANDA 203349

GLAND PHARMA LTD

FDA Drug Application

Application #203349

Application Sponsors

ANDA 203349GLAND PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INTRAVENOUSEQ 20MG BASE/VIAL0ESOMEPRAZOLE SODIUMESOMEPRAZOLE SODIUM
002INJECTABLE;INTRAVENOUSEQ 40MG BASE/VIAL0ESOMEPRAZOLE SODIUMESOMEPRAZOLE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-04-01

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203349
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 20MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ESOMEPRAZOLE SODIUM","activeIngredients":"ESOMEPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-01
        )

)

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