ANDA 062544

NOVARTIS

FDA Drug Application

Application #062544

Application Sponsors

ANDA 062544

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

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

0

DEXACIDIN

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

	ORIG	1	AP	1984-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-01-04
LABELING; Labeling	SUPPL	3	AP	1993-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-04-19

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	9	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62544
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)