NDA 019757

MERCK

FDA Drug Application

Application #019757

Documents

• Label: 2003-06-16

Application Sponsors

NDA 019757

MERCK

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.3%

0

CHIBROXIN

NORFLOXACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-06-17	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1993-04-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	1992-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-06-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	1993-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-04-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-02-24	STANDARD
LABELING; Labeling	SUPPL	9	AP	1999-10-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	2001-02-05	STANDARD

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	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19757
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)