ANDA 203190

HI-TECH PHARMACAL

FDA Drug Application

Application #203190

Application Sponsors

ANDA 203190

HI-TECH PHARMACAL

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION; OPHTHALMIC

0.3%

0

GATIFLOXACIN

GATIFLOXACIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-04-09

Submissions Property Types

ORIG

1

Null

17

CDER Filings

HI-TECH PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203190
            [companyName] => HI-TECH PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GATIFLOXACIN","activeIngredients":"GATIFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION; OPHTHALMIC","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-04-09
        )

)