ANDA 091574

ALCON

FDA Drug Application

Application #091574

Documents

• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Written Request: 1900-01-01

Application Sponsors

ANDA 091574

ALCON

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION; OPHTHALMIC

0.2%; 0.5%

0

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

FDA Submissions

ORIG

1

TA

2010-08-03

Submissions Property Types

ORIG

1

Null

42

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91574
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","activeIngredients":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","strength":"0.2%; 0.5%","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","submission":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","actionType":"0.2%; 0.5%","submissionClassification":"SOLUTION; OPHTHALMIC","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)