HAINAN POLY PHARMACEUTICAL CO LTD FDA Approval ANDA 213078

ANDA 213078

HAINAN POLY PHARMACEUTICAL CO LTD

FDA Drug Application

Application #213078

Application Sponsors

ANDA 213078HAINAN POLY PHARMACEUTICAL CO LTD

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2020-12-22STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

HAINAN POLY PHARMACEUTICAL CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213078
            [companyName] => HAINAN POLY PHARMACEUTICAL CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIVALIRUDIN","activeIngredients":"BIVALIRUDIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [originalApprovals] => [{"actionDate":"12\/22\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-12-22
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.