ANDA 062521

ACTAVIS LABS FL INC

FDA Drug Application

Application #062521

Application Sponsors

ANDA 062521

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION/DROPS;OTIC

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

0

OTOCORT

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62521
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OTOCORT","activeIngredients":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","dosageForm":"SUSPENSION\/DROPS;OTIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OTOCORT","submission":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","submissionClassification":"SUSPENSION\/DROPS;OTIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)