ANDA 207803

AUSTARPHARMA

FDA Drug Application

Application #207803

Application Sponsors

ANDA 207803

AUSTARPHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	54MG	0	FENOFIBRATE	FENOFIBRATE
002	TABLET;ORAL	160MG	0	FENOFIBRATE	FENOFIBRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUSTARPHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207803
            [companyName] => AUSTARPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"54MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-19
        )

)