ANDA 076635

SUN PHARM INDS LTD

FDA Drug Application

Application #076635

Documents

• Letter: 2005-11-01

Application Sponsors

ANDA 076635

SUN PHARM INDS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	54MG	0	FENOFIBRATE	FENOFIBRATE
002	TABLET;ORAL	107MG	0	FENOFIBRATE	FENOFIBRATE
003	TABLET;ORAL	160MG	0	FENOFIBRATE	FENOFIBRATE

FDA Submissions

	ORIG	1	AP	2005-10-31
LABELING; Labeling	SUPPL	9	AP	2018-05-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-10-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-10-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-10-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-06-03	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7

TE Codes

001	Prescription	AB
003	Prescription	AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76635
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"54MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"107MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","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":"107MG","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
        )

)