NDA 018061

MERCK

FDA Drug Application

Application #018061

Documents

• Letter: 2003-03-10

Application Sponsors

NDA 018061

MERCK

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG;10MG

0

TIMOLIDE 10-25

HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1981-12-11	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-02-24	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1988-02-03
LABELING; Labeling	SUPPL	5	AP	1982-09-20
LABELING; Labeling	SUPPL	6	AP	1982-09-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-12-23	STANDARD
LABELING; Labeling	SUPPL	9	AP	1983-08-24
LABELING; Labeling	SUPPL	10	AP	1984-04-18
LABELING; Labeling	SUPPL	11	AP	1984-10-04
LABELING; Labeling	SUPPL	12	AP	1985-09-06
LABELING; Labeling	SUPPL	13	AP	1986-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-08-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	1987-08-26
LABELING; Labeling	SUPPL	17	AP	1987-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-06-01	STANDARD
LABELING; Labeling	SUPPL	19	AP	1988-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1989-04-21	STANDARD
LABELING; Labeling	SUPPL	21	AP	1991-08-12
LABELING; Labeling	SUPPL	22	AP	1993-01-22	STANDARD
LABELING; Labeling	SUPPL	23	AP	1994-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-07-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	1998-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-05-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-02-13	STANDARD
LABELING; Labeling	SUPPL	28	AP	1998-05-15	STANDARD
LABELING; Labeling	SUPPL	29	AP	2003-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-04-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18061
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)