ANDA 078479

APOTEX INC

FDA Drug Application

Application #078479

Documents

• Letter: 2022-02-04

Application Sponsors

ANDA 078479

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.15%

0

BRIMONIDINE TARTRATE

BRIMONIDINE TARTRATE

FDA Submissions

ORIG

1

TA

2015-09-03

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AT

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78479
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIMONIDINE TARTRATE","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.15%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BRIMONIDINE TARTRATE","submission":"BRIMONIDINE TARTRATE","actionType":"0.15%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)