ANCHEN PHARMS FDA Approval ANDA 204009

ANDA 204009

ANCHEN PHARMS

FDA Drug Application

Application #204009

Application Sponsors

ANDA 204009ANCHEN PHARMS

Marketing Status

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

Application Products

001TABLET, EXTENDED RELEASE;ORAL50MG0DESVENLAFAXINEDESVENLAFAXINE
002TABLET, EXTENDED RELEASE;ORAL100MG0DESVENLAFAXINEDESVENLAFAXINE

FDA Submissions

UNKNOWN; ORIG1TA2016-05-20

Submissions Property Types

ORIG1Null19

CDER Filings

ANCHEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204009
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESVENLAFAXINE","activeIngredients":"DESVENLAFAXINE","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DESVENLAFAXINE","activeIngredients":"DESVENLAFAXINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-05-20
        )

)

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