ANDA 200565

TARO

FDA Drug Application

Application #200565

Application Sponsors

ANDA 200565

TARO

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

50MG

0

PHENYTOIN

PHENYTOIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2014-04-17
LABELING; Labeling	SUPPL	2	AP	2017-01-09	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200565
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYTOIN","activeIngredients":"PHENYTOIN","strength":"50MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/09\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/09\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-09
        )

)