Application Sponsors
ANDA 206195 | HISUN PHARM HANGZHOU | |
Marketing Status
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
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
)
)