ANDA 078480

APOTEX INC

FDA Drug Application

Application #078480

Application Sponsors

ANDA 078480

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION; OPHTHALMIC

0.1%

0

BRIMONIDINE TARTRATE

BRIMONIDINE TARTRATE

FDA Submissions

ORIG

1

TA

2012-01-27

Submissions Property Types

ORIG

1

Null

42

TE Codes

001

Prescription

AB

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
        )

)