ANDA 074839

INVATECH

FDA Drug Application

Application #074839

Application Sponsors

ANDA 074839

INVATECH

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

400MG

0

ETODOLAC

ETODOLAC

FDA Submissions

	ORIG	1	AP	1997-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-03-25
LABELING; Labeling	SUPPL	3	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	15
SUPPL	4	Null	15

CDER Filings

PHARMGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74839
            [companyName] => PHARMGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETODOLAC","activeIngredients":"ETODOLAC","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ETODOLAC","submission":"ETODOLAC","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)