ANDA 211525

AMNEAL

FDA Drug Application

Application #211525

Application Sponsors

ANDA 211525

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OTIC

0.3%

0

OFLOXACIN

OFLOXACIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211525
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"OFLOXACIN","activeIngredients":"OFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-30
        )

)