ANDA 090247

HIKMA PHARMS

FDA Drug Application

Application #090247

Application Sponsors

ANDA 090247

HIKMA PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	5MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-05-31
LABELING; Labeling	SUPPL	3	AP	2021-04-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90247
            [companyName] => HIKMA PHARMS
            [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
        )

)