ANDA 089338

SUN PHARM INDUSTRIES

FDA Drug Application

Application #089338

Documents

• Label: 2010-03-17

Application Sponsors

ANDA 089338

SUN PHARM INDUSTRIES

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

324MG

0

QUINIDINE GLUCONATE

QUINIDINE GLUCONATE

FDA Submissions

	ORIG	1	AP	1987-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-07-17
LABELING; Labeling	SUPPL	4	AP	1990-01-12
LABELING; Labeling	SUPPL	5	AP	1990-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1991-07-16
LABELING; Labeling	SUPPL	7	AP	1993-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-06-22
LABELING; Labeling	SUPPL	12	AP	1996-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-12-05
LABELING; Labeling	SUPPL	15	AP	1999-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-06-04
LABELING; Labeling	SUPPL	17	AP	2000-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-07-10
LABELING; Labeling	SUPPL	24	AP	2003-03-31
LABELING; Labeling	SUPPL	36	AP	2010-02-02

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	36	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89338
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINIDINE GLUCONATE","activeIngredients":"QUINIDINE GLUCONATE","strength":"324MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/02\/2010","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/089338s036lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"QUINIDINE GLUCONATE","submission":"QUINIDINE GLUCONATE","actionType":"324MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-02-02
        )

)