ANDA 087810

ANI PHARMS INC

FDA Drug Application

Application #087810

Application Sponsors

ANDA 087810

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

324MG

0

QUINIDINE GLUCONATE

QUINIDINE GLUCONATE

FDA Submissions

	ORIG	1	AP	1982-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1991-08-12
LABELING; Labeling	SUPPL	11	AP	1991-07-02
LABELING; Labeling	SUPPL	12	AP	1992-01-10
LABELING; Labeling	SUPPL	13	AP	1992-04-14
LABELING; Labeling	SUPPL	17	AP	1996-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-10-08
LABELING; Labeling	SUPPL	20	AP	1999-04-30
LABELING; Labeling	SUPPL	21	AP	2001-01-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	18	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87810
            [companyName] => ANI PHARMS INC
            [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
        )

)