Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION; OPHTHALMIC | 0.1% | 0 | BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE |
FDA Submissions
Submissions Property Types
TE Codes
CDER Filings
APOTEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 78480
[companyName] => APOTEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"BRIMONIDINE TARTRATE","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.1%","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BRIMONIDINE TARTRATE","submission":"BRIMONIDINE TARTRATE","actionType":"0.1%","submissionClassification":"SOLUTION; OPHTHALMIC","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)