ANDA 089894

AUROLIFE PHARMA LLC

FDA Drug Application

Application #089894

Application Sponsors

ANDA 089894

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

324MG

0

QUINIDINE GLUCONATE

QUINIDINE GLUCONATE

FDA Submissions

	ORIG	1	AP	1988-12-15
LABELING; Labeling	SUPPL	3	AP	1992-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-04-06
LABELING; Labeling	SUPPL	5	AP	1997-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-06-29
LABELING; Labeling	SUPPL	7	AP	1999-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-05-09

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89894
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINIDINE GLUCONATE","activeIngredients":"QUINIDINE GLUCONATE","strength":"324MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUINIDINE GLUCONATE","submission":"QUINIDINE GLUCONATE","actionType":"324MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)