NDA 020421

BAYER

FDA Drug Application

Application #020421

Application Sponsors

NDA 020421

BAYER

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;VAGINAL

2%

1

FEMSTAT 3

BUTOCONAZOLE NITRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1995-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-01-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

BAYER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20421
            [companyName] => BAYER
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEMSTAT 3","activeIngredients":"BUTOCONAZOLE NITRATE","strength":"2%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FEMSTAT 3","submission":"BUTOCONAZOLE NITRATE","actionType":"2%","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)