YICHANG HUMANWELL FDA Approval ANDA 216766

ANDA 216766

YICHANG HUMANWELL

FDA Drug Application

Application #216766

Application Sponsors

ANDA 216766YICHANG HUMANWELL

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL150MG0BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB2

CDER Filings

YICHANG HUMANWELL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216766
            [companyName] => YICHANG HUMANWELL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPROPION HYDROCHLORIDE","activeIngredients":"BUPROPION HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-09
        )

)

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.