TEVA PHARMS USA FDA Approval ANDA 205807

ANDA 205807

TEVA PHARMS USA

FDA Drug Application

Application #205807

Application Sponsors

ANDA 205807TEVA PHARMS USA

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL600MG0GABAPENTINGABAPENTIN
002TABLET;ORAL800MG0GABAPENTINGABAPENTIN

FDA Submissions

UNKNOWN; ORIG1AP2017-03-10STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205807
            [companyName] => TEVA PHARMS USA
            [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":"03\/10\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-10
        )

)

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