ANDA 203104

TWI PHARMS

FDA Drug Application

Application #203104

Application Sponsors

ANDA 203104

TWI PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

23MG

0

DONEPEZIL HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-10-29
LABELING; Labeling	SUPPL	2	AP	2016-10-04	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-09-24	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TWI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203104
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DONEPEZIL HYDROCHLORIDE","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"23MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/24\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-24
        )

)