ANDA 200691

MYLAN PHARMS INC

FDA Drug Application

Application #200691

Application Sponsors

ANDA 200691

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

50MG

0

PHENYTOIN

PHENYTOIN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-12-26
LABELING; Labeling	SUPPL	2	AP	2017-01-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200691
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYTOIN","activeIngredients":"PHENYTOIN","strength":"50MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/06\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/06\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-06
        )

)