LUPIN LTD FDA Approval ANDA 204983

ANDA 204983

LUPIN LTD

FDA Drug Application

Application #204983

Application Sponsors

ANDA 204983LUPIN LTD

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET, EXTENDED RELEASE;ORAL4MG0FESOTERODINE FUMARATEFESOTERODINE FUMARATE
002TABLET, EXTENDED RELEASE;ORAL8MG0FESOTERODINE FUMARATEFESOTERODINE FUMARATE

FDA Submissions

UNKNOWN; ORIG1TA2015-04-29STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204983
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FESOTERODINE FUMARATE","activeIngredients":"FESOTERODINE FUMARATE","strength":"4MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"FESOTERODINE FUMARATE","activeIngredients":"FESOTERODINE FUMARATE","strength":"8MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/29\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-04-29
        )

)

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