ANDA 074927

ECI PHARMS LLC

FDA Drug Application

Application #074927

Application Sponsors

ANDA 074927

ECI PHARMS LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

400MG

0

ETODOLAC

ETODOLAC

FDA Submissions

	ORIG	1	AP	1997-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-10-08

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

BIOPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74927
            [companyName] => BIOPHARM
            [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
        )

)