Application Sponsors
ANDA 208759 | HISUN PHARM HANGZHOU | |
Marketing Status
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
TE Codes
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
)
)