Application Sponsors
ANDA 210186 | AMNEAL PHARMS NY | |
Marketing Status
Application Products
001 | FOR SUSPENSION;ORAL | EQ 6MG BASE/ML | 0 | OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-02-27 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2021-06-07 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2021-06-07 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 5 | Null | 7 |
SUPPL | 7 | Null | 15 |
TE Codes
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 210186
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-02-27
)
)