ANDA 216798

AUROBINDO PHARMA

FDA Drug Application

Application #216798

Application Sponsors

ANDA 216798

AUROBINDO PHARMA

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

2022-09-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AUROBINDO PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216798
            [companyName] => AUROBINDO PHARMA
            [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":"09\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-27
        )

)