ANDA 212201

YAOPHARMA CO LTD

FDA Drug Application

Application #212201

Application Sponsors

ANDA 212201

YAOPHARMA CO LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	0.5MG	0	ENTECAVIR	ENTECAVIR
002	TABLET;ORAL	1MG	0	ENTECAVIR	ENTECAVIR

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-11-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

YAOPHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212201
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-04
        )

)