ANDA 075753

RHODES PHARMS

FDA Drug Application

Application #075753

Documents

• Label: 2013-02-20
• Letter: 2003-04-10

Application Sponsors

ANDA 075753

RHODES PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	67MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE
002	CAPSULE;ORAL	134MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE
003	CAPSULE;ORAL	200MG	0	FENOFIBRATE (MICRONIZED)	FENOFIBRATE

FDA Submissions

	ORIG	1	AP	2002-04-09
LABELING; Labeling	SUPPL	2	AP	2003-07-31
LABELING; Labeling	SUPPL	3	AP	2003-07-31
LABELING; Labeling	SUPPL	5	AP	2012-02-07
LABELING; Labeling	SUPPL	8	AP	2018-05-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2018-05-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-05-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-06-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

RHODES PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75753
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"67MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"134MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/07\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/075753s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FENOFIBRATE (MICRONIZED)","submission":"FENOFIBRATE","actionType":"67MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENOFIBRATE (MICRONIZED)","submission":"FENOFIBRATE","actionType":"134MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"FENOFIBRATE (MICRONIZED)","submission":"FENOFIBRATE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-02-07
        )

)