ANDA 081031

SUN PHARM INDUSTRIES

FDA Drug Application

Application #081031

Application Sponsors

ANDA 081031

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

300MG

0

QUINIDINE SULFATE

QUINIDINE SULFATE

FDA Submissions

	ORIG	1	AP	1989-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-06-22
LABELING; Labeling	SUPPL	3	AP	1996-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-12-05
LABELING; Labeling	SUPPL	6	AP	1999-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-05-16
LABELING; Labeling	SUPPL	24	AP	2010-02-02

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	24	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81031
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINIDINE SULFATE","activeIngredients":"QUINIDINE SULFATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUINIDINE SULFATE","submission":"QUINIDINE SULFATE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)