ANDA 089534

SUN PHARM INDUSTRIES

FDA Drug Application

Application #089534

Application Sponsors

ANDA 089534

SUN PHARM INDUSTRIES

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG;25MG

0

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

FDA Submissions

	ORIG	1	AP	1987-07-02
LABELING; Labeling	SUPPL	2	AP	1991-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-10-15
LABELING; Labeling	SUPPL	4	AP	1993-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1993-10-15
LABELING; Labeling	SUPPL	6	AP	1995-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-06-22
LABELING; Labeling	SUPPL	9	AP	1996-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-12-05
LABELING; Labeling	SUPPL	13	AP	1998-07-28
LABELING; Labeling	SUPPL	14	AP	2000-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-12-10
LABELING; Labeling	SUPPL	18	AP	2001-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-01-31
LABELING; Labeling	SUPPL	37	AP	2011-12-14
LABELING; Labeling	SUPPL	38	AP	2011-12-14
LABELING; Labeling	SUPPL	40	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	41	AP	2014-09-24	STANDARD
LABELING; Labeling	SUPPL	43	AP	2015-03-20	STANDARD
LABELING; Labeling	SUPPL	46	AP	2019-11-01	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	37	Null	15
SUPPL	38	Null	15
SUPPL	40	Null	15
SUPPL	41	Null	7
SUPPL	43	Null	15
SUPPL	46	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89534
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; SPIRONOLACTONE","strength":"25MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; SPIRONOLACTONE","actionType":"25MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)