ANDA 209601

APOTEX

FDA Drug Application

Application #209601

Application Sponsors

ANDA 209601

APOTEX

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	2018-11-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-07-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-12-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-12-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209601
            [companyName] => APOTEX
            [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\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/18\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/18\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-18
        )

)