ANDA 204598

HETERO LABS LTD III

FDA Drug Application

Application #204598

Application Sponsors

ANDA 204598

HETERO LABS LTD III

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	48MG	0	FENOFIBRATE	FENOFIBRATE
002	TABLET;ORAL	145MG	0	FENOFIBRATE	FENOFIBRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-07-12

Submissions Property Types

ORIG

1

Null

17

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204598
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"48MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"145MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-07-12
        )

)