Application Sponsors
ANDA 216533 | INGENUS PHARMS LLC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.25% BASE | 0 | TIMOLOL MALEATE | TIMOLOL MALEATE |
002 | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | 0 | TIMOLOL MALEATE | TIMOLOL MALEATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-09-13 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AT3 |
002 | Prescription | AT3 |
CDER Filings
INGENUS PHARMS LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 216533
[companyName] => INGENUS PHARMS LLC
[docInserts] => ["",""]
[products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-09-13
)
)