NDA 050322

MERCK

FDA Drug Application

Application #050322

Application Sponsors

NDA 050322

MERCK

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

0

NEODECADRON

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

FDA Submissions

	ORIG	1	AP	1969-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1970-02-06
LABELING; Labeling	SUPPL	7	AP	1984-06-27
LABELING; Labeling	SUPPL	8	AP	1985-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-01-22
LABELING; Labeling	SUPPL	11	AP	1987-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-12-15
LABELING; Labeling	SUPPL	13	AP	1995-09-29
LABELING; Labeling	SUPPL	14	AP	1995-09-29
LABELING; Labeling	SUPPL	15	AP	1995-09-29
LABELING; Labeling	SUPPL	16	AP	1995-09-29
LABELING; Labeling	SUPPL	17	AP	1995-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1970-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1970-04-14
LABELING; Labeling	SUPPL	20	AP	1970-04-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1971-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1971-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1972-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1972-07-18
LABELING; Labeling	SUPPL	25	AP	1972-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1973-04-23
LABELING; Labeling	SUPPL	27	AP	1973-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1975-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1975-10-17
LABELING; Labeling	SUPPL	30	AP	1976-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1976-03-15
LABELING; Labeling	SUPPL	32	AP	1977-04-12
LABELING; Labeling	SUPPL	33	AP	1977-04-18
LABELING; Labeling	SUPPL	34	AP	1977-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1978-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1978-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1980-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1980-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1980-08-06
LABELING; Labeling	SUPPL	40	AP	1980-08-28
LABELING; Labeling	SUPPL	41	AP	1981-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1995-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1995-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1996-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1997-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1998-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1998-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1998-12-29

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	26	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
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

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50322
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)