ANDA 216766

YICHANG HUMANWELL

FDA Drug Application

Application #216766

Application Sponsors

ANDA 216766

YICHANG HUMANWELL

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

150MG

0

BUPROPION HYDROCHLORIDE

BUPROPION HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB2

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
        )

)