ANDA 213457

LUPIN LTD

FDA Drug Application

Application #213457

Application Sponsors

ANDA 213457

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

40MG/ML

0

RUFINAMIDE

RUFINAMIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-11-16	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213457
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"40MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-18
        )

)