ANDA 210128

MYLAN

FDA Drug Application

Application #210128

Documents

• Letter: 2019-08-07

Application Sponsors

ANDA 210128

MYLAN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	2.5MG	0	APIXABAN	APIXABAN
002	TABLET;ORAL	5MG	0	APIXABAN	APIXABAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-12-23	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-05-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210128
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210128Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-23
        )

)