ANDA 204048

ALKEM LABS LTD

FDA Drug Application

Application #204048

Application Sponsors

ANDA 204048

ALKEM LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

RILUZOLE

RILUZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-30
LABELING; Labeling	SUPPL	2	AP	2021-08-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204048
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RILUZOLE","activeIngredients":"RILUZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-30
        )

)