NDA 020526

BAYER HEALTHCARE LLC

FDA Drug Application

Application #020526

Application Sponsors

NDA 020526

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 002

Application Products

002

CREAM, TABLET;TOPICAL, VAGINAL

1%,200MG

1

GYNE-LOTRIMIN 3 COMBINATION PACK

CLOTRIMAZOLE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC Switch	ORIG	1	AP	1996-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-12-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-01-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20526
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GYNE-LOTRIMIN 3 COMBINATION PACK","activeIngredients":"CLOTRIMAZOLE","strength":"1%,200MG","dosageForm":"CREAM, TABLET;TOPICAL, VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GYNE-LOTRIMIN 3 COMBINATION PACK","submission":"CLOTRIMAZOLE","actionType":"1%,200MG","submissionClassification":"CREAM, TABLET;TOPICAL, VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)