ANDA 212598

AUROBINDO PHARMA LTD

FDA Drug Application

Application #212598

Application Sponsors

ANDA 212598

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, DELAYED RELEASE;ORAL	EQ 45MG FENOFIBRIC ACID	0	FENOFIBRIC ACID	CHOLINE FENOFIBRATE
002	CAPSULE, DELAYED RELEASE;ORAL	EQ 135MG FENOFIBRIC ACID	0	FENOFIBRIC ACID	CHOLINE FENOFIBRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-07-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212598
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 45MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 135MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-07-25
        )

)