ANDA 202542

PAR PHARM

FDA Drug Application

Application #202542

Documents

• Letter: 2013-08-20

Application Sponsors

ANDA 202542

PAR PHARM

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

23MG

0

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-07-24
LABELING; Labeling	SUPPL	2	AP	2015-12-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	4	Null	31

CDER Filings

PAR PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202542
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/24\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202542Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/23\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/23\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-23
        )

)