APOTEX INC FDA Approval ANDA 091442

ANDA 091442

APOTEX INC

FDA Drug Application

Application #091442

Application Sponsors

ANDA 091442APOTEX INC

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.2%;EQ 0.5% BASE0BRIMONIDINE TARTRATE AND TIMOLOL MALEATEBRIMONIDINE TARTRATE; TIMOLOL MALEATE

FDA Submissions

N/A; Not ApplicableORIG1TA2018-12-07

Submissions Property Types

ORIG1Null17

TE Codes

001PrescriptionAB

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
        )

)

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