Application Sponsors
ANDA 211661 | HAINAN POLY PHARM | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | 200MG/VIAL | 0 | VORICONAZOLE | VORICONAZOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-11-30 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2021-08-10 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2021-08-10 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2021-08-10 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 7 |
TE Codes
CDER Filings
HAINAN POLY PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 211661
[companyName] => HAINAN POLY PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-11-30
)
)