ANDA 202394

MYLAN PHARMS INC

FDA Drug Application

Application #202394

Application Sponsors

ANDA 202394

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

ENTACAPONE

ENTACAPONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-05-13
LABELING; Labeling	SUPPL	2	AP	2020-03-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202394
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTACAPONE","activeIngredients":"ENTACAPONE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/13\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/30\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/10\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-30
        )

)