NDA 018389

MERCK

FDA Drug Application

Application #018389

Application Sponsors

NDA 018389

MERCK

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

250MG/5ML

0

ALDOMET

METHYLDOPA

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1981-08-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1982-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-12-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	1984-03-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	1985-02-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	1985-10-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	1987-05-11	STANDARD
LABELING; Labeling	SUPPL	8	AP	1988-11-22	STANDARD
LABELING; Labeling	SUPPL	9	AP	1990-09-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	1992-09-03	STANDARD
LABELING; Labeling	SUPPL	11	AP	1994-12-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	1997-08-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	1997-08-05	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	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18389
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)