ANDA 073191

CHARTWELL RX

FDA Drug Application

Application #073191

Application Sponsors

ANDA 073191

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

25MG;50MG

0

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE; TRIAMTERENE

FDA Submissions

	ORIG	1	AP	1991-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1994-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-04-14
LABELING; Labeling	SUPPL	11	AP	1999-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-11-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-04-19
LABELING; Labeling	SUPPL	20	AP	2004-01-05
LABELING; Labeling	SUPPL	27	AP	2008-08-13
LABELING; Labeling	SUPPL	32	AP	2012-04-18

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	32	Null	15

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73191
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","strength":"25MG;50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMTERENE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; TRIAMTERENE","actionType":"25MG;50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)