NDA 016016

MERCK

FDA Drug Application

Application #016016

Application Sponsors

NDA 016016

MERCK

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	150MG;250MG	0	ALDOCLOR-150	CHLOROTHIAZIDE; METHYLDOPA
002	TABLET;ORAL	250MG;250MG	0	ALDOCLOR-250	CHLOROTHIAZIDE; METHYLDOPA

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1968-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1975-06-06	STANDARD
LABELING; Labeling	SUPPL	30	AP	1976-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1976-11-09	STANDARD
LABELING; Labeling	SUPPL	32	AP	1978-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1978-02-15	STANDARD
LABELING; Labeling	SUPPL	34	AP	1978-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1979-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1979-06-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1978-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1978-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1979-03-09	STANDARD
LABELING; Labeling	SUPPL	40	AP	1979-09-18	STANDARD
LABELING; Labeling	SUPPL	41	AP	1979-07-03	STANDARD
LABELING; Labeling	SUPPL	42	AP	1979-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1981-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1980-11-14	STANDARD
LABELING; Labeling	SUPPL	45	AP	1981-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1981-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1981-04-09	STANDARD
LABELING; Labeling	SUPPL	48	AP	1981-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1981-06-17	STANDARD
LABELING; Labeling	SUPPL	50	AP	1981-09-23	STANDARD
LABELING; Labeling	SUPPL	51	AP	1987-05-08	STANDARD
LABELING; Labeling	SUPPL	52	AP	1982-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1983-12-23	STANDARD
LABELING; Labeling	SUPPL	54	AP	1984-04-03	STANDARD
LABELING; Labeling	SUPPL	55	AP	1984-09-24	STANDARD
LABELING; Labeling	SUPPL	56	AP	1986-01-14	STANDARD
LABELING; Labeling	SUPPL	57	AP	1986-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1988-08-15	STANDARD
LABELING; Labeling	SUPPL	59	AP	1987-08-26	STANDARD
LABELING; Labeling	SUPPL	60	AP	1988-04-21	STANDARD
LABELING; Labeling	SUPPL	61	AP	1992-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1988-09-06	STANDARD
LABELING; Labeling	SUPPL	63	AP	1990-09-13	STANDARD
LABELING; Labeling	SUPPL	64	AP	1992-09-17	STANDARD
LABELING; Labeling	SUPPL	65	AP	1994-06-30	STANDARD
LABELING; Labeling	SUPPL	66	AP	1994-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1994-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	1997-05-23	STANDARD
LABELING; Labeling	SUPPL	69	AP	1997-08-05	STANDARD
LABELING; Labeling	SUPPL	70	AP	1999-08-22	STANDARD

Submissions Property Types

ORIG	1	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
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	0
SUPPL	68	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16016
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)