ANDA 209549

WATSON LABS TEVA

FDA Drug Application

Application #209549

Documents

• Letter: 2018-08-17

Application Sponsors

ANDA 209549

WATSON LABS TEVA

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	2018-07-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-12-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209549
            [companyName] => WATSON LABS TEVA
            [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":"07\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209549Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-27
        )

)