ANDA 209888

EDENBRIDGE PHARMS

FDA Drug Application

Application #209888

Application Sponsors

ANDA 209888

EDENBRIDGE PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	400MG	0	ETODOLAC	ETODOLAC
002	TABLET;ORAL	500MG	0	ETODOLAC	ETODOLAC

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EDENBRIDGE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209888
            [companyName] => EDENBRIDGE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETODOLAC","activeIngredients":"ETODOLAC","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ETODOLAC","activeIngredients":"ETODOLAC","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-30
        )

)