ANDA 211863

LUPIN LTD

FDA Drug Application

Application #211863

Application Sponsors

ANDA 211863

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	10MG	0	LEFLUNOMIDE	LEFLUNOMIDE
002	TABLET;ORAL	20MG	0	LEFLUNOMIDE	LEFLUNOMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-02-04

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211863
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEFLUNOMIDE","activeIngredients":"LEFLUNOMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-04
        )

)