ANCHEN PHARMS FDA Approval ANDA 091190

ANDA 091190

ANCHEN PHARMS

FDA Drug Application

Application #091190

Application Sponsors

ANDA 091190ANCHEN PHARMS

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 7.5MG BASE0DARIFENACIN HYDROBROMIDEDARIFENACIN HYDROBROMIDE
002TABLET, EXTENDED RELEASE;ORALEQ 15MG BASE0DARIFENACIN HYDROBROMIDEDARIFENACIN HYDROBROMIDE

FDA Submissions

ORIG1AP2015-03-13

Submissions Property Types

ORIG1Null15

CDER Filings

ANCHEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91190
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARIFENACIN HYDROBROMIDE","activeIngredients":"DARIFENACIN HYDROBROMIDE","strength":"EQ 7.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DARIFENACIN HYDROBROMIDE","activeIngredients":"DARIFENACIN HYDROBROMIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DARIFENACIN HYDROBROMIDE","submission":"DARIFENACIN HYDROBROMIDE","actionType":"EQ 7.5MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DARIFENACIN HYDROBROMIDE","submission":"DARIFENACIN HYDROBROMIDE","actionType":"EQ 15MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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