Application Sponsors
ANDA 090075 | HISUN PHARM HANGZHOU | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 50MG/25ML (2MG/ML) | 0 | EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE |
002 | INJECTABLE;INJECTION | 200MG/100ML (2MG/ML) | 0 | EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
HISUN PHARM HANGZHOU
cder:Array
(
[0] => Array
(
[ApplNo] => 90075
[companyName] => HISUN PHARM HANGZHOU
[docInserts] => ["",""]
[products] => [{"drugName":"EPIRUBICIN HYDROCHLORIDE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPIRUBICIN HYDROCHLORIDE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"EPIRUBICIN HYDROCHLORIDE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"50MG\/25ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"EPIRUBICIN HYDROCHLORIDE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)