ANDA 208759

HISUN PHARM HANGZHOU

FDA Drug Application

Application #208759

Application Sponsors

ANDA 208759

HISUN PHARM HANGZHOU

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

DAUNORUBICIN HYDROCHLORIDE

DAUNORUBICIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2020-12-01

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HISUN PHARM HANGZHOU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208759
            [companyName] => HISUN PHARM HANGZHOU
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAUNORUBICIN HYDROCHLORIDE","activeIngredients":"DAUNORUBICIN HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/01\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/09\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-12-01
        )

)