ANDA 091300

APOTEX CORP

FDA Drug Application

Application #091300

Application Sponsors

ANDA 091300

APOTEX CORP

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

RILUZOLE

RILUZOLE

FDA Submissions

	ORIG	1	AP	2013-06-18
LABELING; Labeling	SUPPL	4	AP	2021-09-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91300
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"RILUZOLE","activeIngredients":"RILUZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RILUZOLE","submission":"RILUZOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)