ANDA 203042

MYLAN PHARMS INC

FDA Drug Application

Application #203042

Application Sponsors

ANDA 203042

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

RILUZOLE

RILUZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-07-01
LABELING; Labeling	SUPPL	3	AP	2021-09-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203042
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RILUZOLE","activeIngredients":"RILUZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-07-01
        )

)