NDA 018713

BAYER HLTHCARE

FDA Drug Application

Application #018713

Documents

• Label: 2002-12-15
• Letter: 2002-12-15
• Review: 2007-07-06
• Review: 2007-07-06
• Review: 2007-07-06

Application Sponsors

NDA 018713

BAYER HLTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

TROCHE/LOZENGE;ORAL

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

MYCELEX

CLOTRIMAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1983-06-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	1985-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-06-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-01-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-01-15	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	1992-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1990-01-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	1991-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-03-26	STANDARD
LABELING; Labeling	SUPPL	19	AP	2002-12-15	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18713
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)