ANDA 077975

SUN PHARM INDUSTRIES

FDA Drug Application

Application #077975

Documents

• Label: 2011-04-19
• Letter: 2009-12-24

Application Sponsors

ANDA 077975

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE
002	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	0	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-12-11
LABELING; Labeling	SUPPL	2	AP	2011-02-16

Submissions Property Types

ORIG	1	Null	3
SUPPL	2	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77975
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/11\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/077975s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DONEPEZIL HYDROCHLORIDE","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-12-11
        )

)