ANDA 203008

AM REGENT

FDA Drug Application

Application #203008

Application Sponsors

ANDA 203008

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

FLOXURIDINE

FLOXURIDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-22

Submissions Property Types

ORIG

1

Null

19

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203008
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLOXURIDINE","activeIngredients":"FLOXURIDINE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-22
        )

)