ANDA 078282

APOTEX INC

FDA Drug Application

Application #078282

Application Sponsors

ANDA 078282

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

LEVOFLOXACIN

LEVOFLOXACIN

FDA Submissions

ORIG

1

AP

2010-12-20

Submissions Property Types

ORIG

1

Null

7

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78282
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)