ANDA 211122

GRAVITI PHARMS

FDA Drug Application

Application #211122

Application Sponsors

ANDA 211122

GRAVITI PHARMS

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	2020-03-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-04-05	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

GRAVITI PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211122
            [companyName] => GRAVITI PHARMS
            [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":"03\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-18
        )

)