HI TECH FDA Approval ANDA 203395

ANDA 203395

HI TECH

FDA Drug Application

Application #203395

Application Sponsors

ANDA 203395HI TECH

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.09% ACID0BROMFENAC SODIUMBROMFENAC SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2014-01-22

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT2

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203395
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BROMFENAC SODIUM","activeIngredients":"BROMFENAC SODIUM","strength":"EQ 0.09% ACID","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-01-22
        )

)

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