ANDA 212308

ZYDUS

FDA Drug Application

Application #212308

Documents

• Letter: 2019-04-26

Application Sponsors

ANDA 212308

ZYDUS

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

2019-04-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212308
            [companyName] => ZYDUS
            [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":"04\/24\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212308Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-24
        )

)