MYLAN PHARMS INC FDA Approval ANDA 090521

ANDA 090521

MYLAN PHARMS INC

FDA Drug Application

Application #090521

Application Sponsors

ANDA 090521MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL5MG0DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE
002TABLET;ORAL10MG0DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE

FDA Submissions

ORIG1AP2011-05-31
LABELING; LabelingSUPPL3AP2015-02-25STANDARD
LABELING; LabelingSUPPL5AP2017-01-03STANDARD
LABELING; LabelingSUPPL6AP2021-05-04STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL5Null7
SUPPL6Null7

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90521
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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