ANDA 083232

WATSON LABS TEVA

FDA Drug Application

Application #083232

Documents

• Review: 2003-08-05

Application Sponsors

ANDA 083232

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1975-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1982-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1983-05-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1983-05-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1985-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1985-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1985-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1987-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1987-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1987-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1988-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1988-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1988-09-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1988-09-20
LABELING; Labeling	SUPPL	47	AP	1988-09-20
LABELING; Labeling	SUPPL	49	AP	1989-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1990-06-29
LABELING; Labeling	SUPPL	51	AP	1989-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1990-11-19
LABELING; Labeling	SUPPL	54	AP	1992-10-06
LABELING; Labeling	SUPPL	55	AP	1993-08-03
LABELING; Labeling	SUPPL	56	AP	1995-09-12
LABELING; Labeling	SUPPL	57	AP	1995-12-13

Submissions Property Types

SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	50	Null	0
SUPPL	53	Null	0

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83232
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)