NDA 018182

BAYER HEALTHCARE LLC

FDA Drug Application

Application #018182

Application Sponsors

NDA 018182

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;VAGINAL

100MG

0

MYCELEX-7

CLOTRIMAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1979-02-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1981-01-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	1982-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-06-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	1990-11-15
EFFICACY; Efficacy	SUPPL	9	AP	1991-12-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-02-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	1992-10-08
LABELING; Labeling	SUPPL	12	AP	1993-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-09-07	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18182
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCELEX-7","activeIngredients":"CLOTRIMAZOLE","strength":"100MG","dosageForm":"TABLET;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCELEX-7","submission":"CLOTRIMAZOLE","actionType":"100MG","submissionClassification":"TABLET;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)