ANDA 062480

NOVARTIS

FDA Drug Application

Application #062480

Application Sponsors

ANDA 062480

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.3% BASE

0

GENTACIDIN

GENTAMICIN SULFATE

FDA Submissions

	ORIG	1	AP	1984-03-30
LABELING; Labeling	SUPPL	2	AP	1993-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-06-10
LABELING; Labeling	SUPPL	5	AP	1994-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-08-22
LABELING; Labeling	SUPPL	7	AP	1999-02-12
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	7	Null	0
SUPPL	9	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62480
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)