ANDA 210476

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210476

Application Sponsors

ANDA 210476

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	48MG	0	FENOFIBRATE	FENOFIBRATE
002	TABLET;ORAL	145MG	0	FENOFIBRATE	FENOFIBRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-09	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-04-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	7	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210476
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"48MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"145MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-09
        )

)