ANDA 204912

AKORN INC

FDA Drug Application

Application #204912

Application Sponsors

ANDA 204912

AKORN INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;OPHTHALMIC

0.5%

0

TIMOLOL MALEATE

TIMOLOL MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-09-24

STANDARD

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204912
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"0.5%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-24
        )

)