ALVOGEN FDA Approval ANDA 090395

ANDA 090395

ALVOGEN

FDA Drug Application

Application #090395

Application Sponsors

ANDA 090395ALVOGEN

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OTIC0.3%0OFLOXACINOFLOXACIN

FDA Submissions

ORIG1AP2009-08-11

Submissions Property Types

ORIG1Null7

CDER Filings

ALVOGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90395
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OFLOXACIN","activeIngredients":"OFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OFLOXACIN","submission":"OFLOXACIN","actionType":"0.3%","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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