ANDA 209668

ZYDUS PHARMS

FDA Drug Application

Application #209668

Application Sponsors

ANDA 209668

ZYDUS PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	7MG	0	TERIFLUNOMIDE	TERIFLUNOMIDE
002	TABLET;ORAL	14MG	0	TERIFLUNOMIDE	TERIFLUNOMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209668
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"14MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-30
        )

)