LUPIN LTD FDA Approval ANDA 209306

ANDA 209306

LUPIN LTD

FDA Drug Application

Application #209306

Application Sponsors

ANDA 209306LUPIN LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL600MG0GABAPENTINGABAPENTIN
002TABLET;ORAL800MG0GABAPENTINGABAPENTIN

FDA Submissions

UNKNOWN; ORIG1AP2018-08-24STANDARD
LABELING; LabelingSUPPL2AP2021-11-12STANDARD
LABELING; LabelingSUPPL3AP2021-11-12STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null7

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209306
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-24
        )

)

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