ANDA 088791

NOVARTIS

FDA Drug Application

Application #088791

Application Sponsors

ANDA 088791

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;OPHTHALMIC

0.5%;10%

0

VASOCIDIN

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

FDA Submissions

	ORIG	1	AP	1984-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-09-17
LABELING; Labeling	SUPPL	6	AP	1991-12-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-02-15
LABELING; Labeling	SUPPL	8	AP	1993-01-29
LABELING; Labeling	SUPPL	9	AP	1994-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	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

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88791
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)