ANDA 209623

MSN

FDA Drug Application

Application #209623

Application Sponsors

ANDA 209623

MSN

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	2019-04-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-12-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-04-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-11-01	STANDARD

Submissions Property Types

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

CDER Filings

MSN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209623
            [companyName] => MSN
            [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":"04\/24\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-24
        )

)