NDA 050324

MERCK

FDA Drug Application

Application #050324

Application Sponsors

NDA 050324

MERCK

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;OPHTHALMIC

EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM

0

NEODECADRON

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

FDA Submissions

	ORIG	1	AP	1969-09-15
LABELING; Labeling	SUPPL	2	AP	1969-11-03
LABELING; Labeling	SUPPL	3	AP	1984-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-09-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1969-12-24
LABELING; Labeling	SUPPL	6	AP	1970-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-12-15
LABELING; Labeling	SUPPL	8	AP	1995-11-20
LABELING; Labeling	SUPPL	9	AP	1995-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-03-11
LABELING; Labeling	SUPPL	11	AP	1995-11-20
LABELING; Labeling	SUPPL	12	AP	1995-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1972-08-31
LABELING; Labeling	SUPPL	14	AP	1972-09-07
LABELING; Labeling	SUPPL	15	AP	1973-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1975-03-07
EFFICACY; Efficacy	SUPPL	17	AP	1976-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1976-02-23
LABELING; Labeling	SUPPL	19	AP	1977-03-23
EFFICACY; Efficacy	SUPPL	20	AP	1978-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1978-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1980-04-01
LABELING; Labeling	SUPPL	23	AP	1980-08-28
LABELING; Labeling	SUPPL	24	AP	1981-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1981-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1981-09-29
LABELING; Labeling	SUPPL	28	AP	1981-10-13
LABELING; Labeling	SUPPL	29	AP	1982-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1984-09-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1995-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1996-04-16

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
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	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50324
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)