ANDA 079084

APOTEX INC

FDA Drug Application

Application #079084

Application Sponsors

ANDA 079084

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.3%

0

GATIFLOXACIN

GATIFLOXACIN

FDA Submissions

	ORIG	1	AP	2011-08-19
LABELING; Labeling	SUPPL	2	AP	2015-09-21	STANDARD

Submissions Property Types

ORIG	1	Null	3
SUPPL	2	Null	7

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79084
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GATIFLOXACIN","activeIngredients":"GATIFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GATIFLOXACIN","submission":"GATIFLOXACIN","actionType":"0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)