Application Sponsors
ANDA 090016 | HISUN PHARM HANGZHOU | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | 0 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE |
002 | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | 0 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE |
FDA Submissions
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
HISUN PHARM HANGZHOU
cder:Array
(
[0] => Array
(
[ApplNo] => 90016
[companyName] => HISUN PHARM HANGZHOU
[docInserts] => ["",""]
[products] => [{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"40MG\/2ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"100MG\/5ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)