ANDA 201573

ANCHEN PHARMS

FDA Drug Application

Application #201573

Documents

• Letter: 2013-07-22
• Label: 2013-09-19

Application Sponsors

ANDA 201573

ANCHEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-07-18
LABELING; Labeling	SUPPL	6	AP	2015-07-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15
SUPPL	10	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201573
            [companyName] => ANCHEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 135MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 45MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/18\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201573Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/18\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201573Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201573Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/29\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/06\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-29
        )

)