ANDA 080751

NOVARTIS

FDA Drug Application

Application #080751

Application Sponsors

ANDA 080751

NOVARTIS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SOLUTION/DROPS;OPHTHALMIC	EQ 0.11% PHOSPHATE	0	INFLAMASE MILD	PREDNISOLONE SODIUM PHOSPHATE
002	SOLUTION/DROPS;OPHTHALMIC	EQ 0.9% PHOSPHATE	0	INFLAMASE FORTE	PREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

	ORIG	1	AP	1973-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-08-15
LABELING; Labeling	SUPPL	9	AP	1988-06-17
LABELING; Labeling	SUPPL	10	AP	1989-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1989-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1989-06-02
LABELING; Labeling	SUPPL	16	AP	1991-04-01
LABELING; Labeling	SUPPL	17	AP	1992-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-10-15
LABELING; Labeling	SUPPL	21	AP	1996-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-04-19

Submissions Property Types

ORIG	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80751
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)