NDA 018183

BAYER HEALTHCARE LLC

FDA Drug Application

Application #018183

Application Sponsors

NDA 018183

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;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	8	AP	1991-04-01
LABELING; Labeling	SUPPL	9	AP	1991-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-05-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	1995-04-03
LABELING; Labeling	SUPPL	14	AP	1996-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-08-29	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	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

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18183
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCELEX","activeIngredients":"CLOTRIMAZOLE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCELEX","submission":"CLOTRIMAZOLE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)