Application Sponsors
Marketing Status
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | 0.2%;EQ 0.5% BASE | 0 | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | BRIMONIDINE TARTRATE; TIMOLOL MALEATE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | TA | 2018-12-07 | |
Submissions Property Types
TE Codes
CDER Filings
APOTEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91442
[companyName] => APOTEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"BRIMONIDINE TARTRATE AND TIMOLOL MALEATE","activeIngredients":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","strength":"0.2%;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BRIMONIDINE TARTRATE AND TIMOLOL MALEATE","submission":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","actionType":"0.2%;EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)