ANDA 076433

RHODES PHARMS

FDA Drug Application

Application #076433

Application Sponsors

ANDA 076433

RHODES PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2005-05-13
LABELING; Labeling	SUPPL	2	AP	2010-01-04
LABELING; Labeling	SUPPL	3	AP	2010-04-30
LABELING; Labeling	SUPPL	4	AP	2011-05-08
LABELING; Labeling	SUPPL	6	AP	2013-08-06	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76433
            [companyName] => RHODES PHARMS
            [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":"FENOFIBRATE","submission":"FENOFIBRATE","actionType":"54MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENOFIBRATE","submission":"FENOFIBRATE","actionType":"160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)