Application Sponsors
ANDA 091106 | JIANGSU HANSOH PHARM | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | EQ 10MG BASE/ML | 0 | VINORELBINE TARTRATE | VINORELBINE TARTRATE |
FDA Submissions
| ORIG | 1 | AP | 2012-09-26 | |
LABELING; Labeling | SUPPL | 5 | AP | 2020-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2020-07-27 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2020-08-20 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 9 | Null | 7 |
TE Codes
CDER Filings
JIANGSU HANSOH PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 91106
[companyName] => JIANGSU HANSOH PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"VINORELBINE TARTRATE","activeIngredients":"VINORELBINE TARTRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VINORELBINE TARTRATE","submission":"VINORELBINE TARTRATE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)