NDA 050616

NOVARTIS

FDA Drug Application

Application #050616

Documents

• Letter: 2004-06-28
• Letter: 2004-07-21
• Label: 2003-03-26
• Label: 2004-07-21
• Review: 2003-09-11
• Letter: 2004-06-28
• Letter: 2003-03-26
• Letter: 2004-07-21
• Label: 2004-06-28
• Label: 2004-06-28
• Label: 2004-07-21
• Letter: 2020-04-28
• Label: 2020-04-28
• Letter: 2021-05-17
• Letter: 2021-05-17
• Label: 2021-05-18
• Label: 2021-05-18

Application Sponsors

NDA 050616

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;OPHTHALMIC

0.1%;0.3%

1

TOBRADEX

DEXAMETHASONE; TOBRAMYCIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1988-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-08-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	1992-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-02-03	STANDARD
LABELING; Labeling	SUPPL	7	AP	1994-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-03-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	1996-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-11-29	STANDARD
LABELING; Labeling	SUPPL	11	AP	1999-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2003-03-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2003-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-12-11	STANDARD
LABELING; Labeling	SUPPL	19	AP	2003-03-18	STANDARD
LABELING; Labeling	SUPPL	21	AP	2004-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2004-07-15	STANDARD
LABELING; Labeling	SUPPL	39	AP	2020-04-24	STANDARD
LABELING; Labeling	SUPPL	40	AP	2021-05-14	STANDARD
LABELING; Labeling	SUPPL	41	AP	2021-05-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	22	Null	0
SUPPL	39	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50616
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)