NDA 020574

BAYER HEALTHCARE LLC

FDA Drug Application

Application #020574

Documents

• Letter: 2010-04-13
• Review: 1998-11-24
• Letter: 1998-11-24
• Label: 1998-11-24
• Label: 2010-04-13

Application Sponsors

NDA 020574

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;VAGINAL

2%

1

GYNE-LOTRIMIN 3

CLOTRIMAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-09-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-01-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2010-04-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	6

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20574
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GYNE-LOTRIMIN 3","activeIngredients":"CLOTRIMAZOLE","strength":"2%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/12\/2010","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020574s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20574lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GYNE-LOTRIMIN 3","submission":"CLOTRIMAZOLE","actionType":"2%","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-04-12
        )

)