NDA 018181

BAYER HLTHCARE

FDA Drug Application

Application #018181

Application Sponsors

NDA 018181

BAYER HLTHCARE

Marketing Status

• Discontinued: 001
• Over-the-counter: 002

Application Products

001	SOLUTION;TOPICAL	1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MYCELEX	CLOTRIMAZOLE
002	Solution; Topical	1%	0	MYCELEX	CLOTRIMAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1979-01-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	1990-03-16
LABELING; Labeling	SUPPL	6	AP	1991-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-05-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	1995-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-05-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-08-29	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18181
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)