ANDA 205438

HI TECH

FDA Drug Application

Application #205438

Application Sponsors

ANDA 205438

HI TECH

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1%

0

TRIFLURIDINE

TRIFLURIDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205438
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIFLURIDINE","activeIngredients":"TRIFLURIDINE","strength":"1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-28
        )

)