ALKEM LABS LTD FDA Approval ANDA 208644

ANDA 208644

ALKEM LABS LTD

FDA Drug Application

Application #208644

Application Sponsors

ANDA 208644ALKEM LABS LTD

Marketing Status

Prescription001

Application Products

001TABLET, DELAYED RELEASE;ORAL20MG0RABEPRAZOLE SODIUMRABEPRAZOLE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2018-04-24STANDARD
LABELING; LabelingSUPPL2AP2018-11-19STANDARD
LABELING; LabelingSUPPL10AP2021-09-14STANDARD
LABELING; LabelingSUPPL14AP2022-09-14STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL10Null15
SUPPL14Null7

TE Codes

001PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208644
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RABEPRAZOLE SODIUM","activeIngredients":"RABEPRAZOLE SODIUM","strength":"20MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/19\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-11-19
        )

)

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