NDA 018201

MERCK

FDA Drug Application

Application #018201

Documents

• Label: 2002-03-21
• Letter: 2002-03-21
• Letter: 2003-03-10
• Review: 2002-05-30

Application Sponsors

NDA 018201

MERCK

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 5MG ANHYDROUS;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

MODURETIC 5-50

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1981-10-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1984-01-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	1984-04-19	STANDARD
LABELING; Labeling	SUPPL	10	AP	1984-08-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	1985-02-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	1986-07-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	1985-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-09-10	STANDARD
LABELING; Labeling	SUPPL	15	AP	1988-05-05	STANDARD
LABELING; Labeling	SUPPL	16	AP	1985-11-01	STANDARD
LABELING; Labeling	SUPPL	17	AP	1986-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-08-15	STANDARD
LABELING; Labeling	SUPPL	19	AP	1987-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1987-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1987-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1988-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-03-29	STANDARD
LABELING; Labeling	SUPPL	25	AP	1989-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1991-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1992-03-26	STANDARD
LABELING; Labeling	SUPPL	30	AP	1992-09-17	STANDARD
LABELING; Labeling	SUPPL	31	AP	1992-10-01	STANDARD
LABELING; Labeling	SUPPL	32	AP	1993-12-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1995-11-29	STANDARD
LABELING; Labeling	SUPPL	34	AP	1998-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1998-02-12	STANDARD
LABELING; Labeling	SUPPL	36	AP	2001-09-18	STANDARD
LABELING; Labeling	SUPPL	37	AP	2002-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2002-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2002-06-24	STANDARD
LABELING; Labeling	SUPPL	40	AP	2003-02-25	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	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	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18201
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)