NDA 020525

BAYER HEALTHCARE LLC

FDA Drug Application

Application #020525

Application Sponsors

NDA 020525

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;VAGINAL

200MG

1

GYNE-LOTRIMIN 3

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	1999-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-09-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20525
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GYNE-LOTRIMIN 3","activeIngredients":"CLOTRIMAZOLE","strength":"200MG","dosageForm":"TABLET;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GYNE-LOTRIMIN 3","submission":"CLOTRIMAZOLE","actionType":"200MG","submissionClassification":"TABLET;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)