NDA 018052

BAYER HEALTHCARE LLC

FDA Drug Application

Application #018052

Documents

• Letter: 2010-04-14
• Label: 2015-01-12

Application Sponsors

NDA 018052

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 002

Application Products

002

CREAM;VAGINAL

1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

GYNE-LOTRIMIN

CLOTRIMAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1978-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1980-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1981-03-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	1986-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1981-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1986-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1987-06-18	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	1990-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-06-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1993-09-22	STANDARD
LABELING; Labeling	SUPPL	19	AP	1992-04-14
LABELING; Labeling	SUPPL	20	AP	1992-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-04-21	STANDARD
LABELING; Labeling	SUPPL	22	AP	1992-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1993-04-15	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	1993-04-26	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-12-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-01-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-09-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-02-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-01-16	STANDARD
LABELING; Labeling	SUPPL	32	AP	2010-04-12	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	6

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18052
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GYNE-LOTRIMIN","activeIngredients":"CLOTRIMAZOLE","strength":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/12\/2010","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/018052Orig1s032lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GYNE-LOTRIMIN","submission":"CLOTRIMAZOLE","actionType":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-04-12
        )

)