YAOPHARMA CO LTD FDA Approval ANDA 212201

ANDA 212201

YAOPHARMA CO LTD

FDA Drug Application

Application #212201

Application Sponsors

ANDA 212201YAOPHARMA CO LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL0.5MG0ENTECAVIRENTECAVIR
002TABLET;ORAL1MG0ENTECAVIRENTECAVIR

FDA Submissions

UNKNOWN; ORIG1AP2019-11-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

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
        )

)

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