ANDA 070185

NOVARTIS

FDA Drug Application

Application #070185

Application Sponsors

ANDA 070185

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.1%

0

FLUOR-OP

FLUOROMETHOLONE

FDA Submissions

	ORIG	1	AP	1986-02-27
LABELING; Labeling	SUPPL	2	AP	1988-06-20
LABELING; Labeling	SUPPL	3	AP	1992-10-20
LABELING; Labeling	SUPPL	4	AP	1994-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-04-19

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70185
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)