Application Sponsors
ANDA 201949 | WATSON LABS TEVA | |
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 | AP | 2022-10-04 | |
Submissions Property Types
TE Codes
CDER Filings
WATSON LABS TEVA
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(
[0] => Array
(
[ApplNo] => 201949
[companyName] => WATSON LABS TEVA
[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":"10\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-10-04
)
)