ANDA 206195

HISUN PHARM HANGZHOU

FDA Drug Application

Application #206195

Application Sponsors

ANDA 206195

HISUN PHARM HANGZHOU

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 20MG BASE/VIAL

0

DAUNORUBICIN HYDROCHLORIDE

DAUNORUBICIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HISUN PHARM HANGZHOU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206195
            [companyName] => HISUN PHARM HANGZHOU
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAUNORUBICIN HYDROCHLORIDE","activeIngredients":"DAUNORUBICIN HYDROCHLORIDE","strength":"EQ 20MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-25
        )

)