NDA 050065

NOVARTIS

FDA Drug Application

Application #050065

Documents

• Letter: 2003-07-28
• Letter: 2004-07-21
• Label: 2003-07-28
• Label: 2004-07-21
• Letter: 2003-07-28
• Letter: 2004-07-21
• Label: 2003-07-28
• Label: 2004-07-21
• Label: 2017-04-13
• Letter: 2017-04-14
• Label: 2017-12-19
• Letter: 2017-12-27
• Letter: 2021-05-17
• Label: 2021-05-18

Application Sponsors

NDA 050065

NOVARTIS

Marketing Status

• Prescription: 002

Application Products

002

OINTMENT;OPHTHALMIC

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

1

MAXITROL

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1963-07-19	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-11-23
LABELING; Labeling	SUPPL	3	AP	1983-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-06-30
LABELING; Labeling	SUPPL	7	AP	1987-06-30
LABELING; Labeling	SUPPL	8	AP	1987-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1970-06-04
LABELING; Labeling	SUPPL	15	AP	1971-07-22
LABELING; Labeling	SUPPL	16	AP	1971-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1972-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1972-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1972-07-12
LABELING; Labeling	SUPPL	20	AP	1972-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1973-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1973-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1973-02-20
LABELING; Labeling	SUPPL	24	AP	1978-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1981-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1981-06-17
LABELING; Labeling	SUPPL	27	AP	1982-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1983-07-11
LABELING; Labeling	SUPPL	29	AP	1995-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1996-03-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1996-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1998-05-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1999-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1999-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1999-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2001-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2003-07-23
LABELING; Labeling	SUPPL	40	AP	2003-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2002-12-11
LABELING; Labeling	SUPPL	43	AP	2004-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2004-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	2012-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	2012-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2015-10-06
LABELING; Labeling	SUPPL	61	AP	2017-04-12	STANDARD
LABELING; Labeling	SUPPL	64	AP	2017-12-18	STANDARD
LABELING; Labeling	SUPPL	65	AP	2021-05-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	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	41	Null	0
SUPPL	44	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	15
SUPPL	64	Null	6
SUPPL	65	Null	7

TE Codes

002

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50065
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)