CSPC OUYI FDA Approval ANDA 205072

ANDA 205072

CSPC OUYI

FDA Drug Application

Application #205072

Application Sponsors

ANDA 205072CSPC OUYI

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORALEQ 500MG BASE0CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATE

FDA Submissions

UNKNOWN; ORIG1AP2017-07-28STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

CSPC OUYI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205072
            [companyName] => CSPC OUYI
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFADROXIL","activeIngredients":"CEFADROXIL\/CEFADROXIL HEMIHYDRATE","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-28
        )

)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.