MYLAN LABS LTD FDA Approval ANDA 208580

ANDA 208580

MYLAN LABS LTD

FDA Drug Application

Application #208580

Application Sponsors

ANDA 208580MYLAN LABS LTD

Marketing Status

Discontinued001

Application Products

001INJECTABLE;IV (INFUSION)EQ 40MG BASE/VIAL0PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2018-05-04STANDARD
LABELING; LabelingSUPPL2AP2021-04-08STANDARD
LABELING; LabelingSUPPL3AP2021-04-08STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null15

CDER Filings

MYLAN LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208580
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-04
        )

)

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