ANDA 204964

LUPIN LTD

FDA Drug Application

Application #204964

Documents

• Letter: 2022-09-08

Application Sponsors

ANDA 204964

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	100MG	0	RUFINAMIDE	RUFINAMIDE
002	TABLET;ORAL	200MG	0	RUFINAMIDE	RUFINAMIDE
003	TABLET;ORAL	400MG	0	RUFINAMIDE	RUFINAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

002	Prescription	AB
003	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204964
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RUFINAMIDE","activeIngredients":"RUFINAMIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-17
        )

)