ANDA 080235

NOVARTIS

FDA Drug Application

Application #080235

Application Sponsors

ANDA 080235

NOVARTIS

Marketing Status

• Discontinued: 002

Application Products

002

SOLUTION/DROPS;OPHTHALMIC

0.1%

0

VASOCON

NAPHAZOLINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1971-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-08-11
LABELING; Labeling	SUPPL	8	AP	1991-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-10-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-04-19

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80235
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)