NDA 021043

BAYER HEALTHCARE LLC

FDA Drug Application

Application #021043

Documents

• Letter: 2006-05-30
• Letter: 2000-03-07
• Letter: 2004-12-30
• Label: 2000-03-07
• Review: 2004-06-16

Application Sponsors

NDA 021043

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL;TOPICAL

4%;EQ 0.33% BASE

0

RID MOUSSE

PIPERONYL BUTOXIDE; PYRETHRINS

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-10-25	STANDARD
LABELING; Labeling	SUPPL	5	AP	2004-12-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2006-05-26	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21043
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RID MOUSSE","activeIngredients":"PIPERONYL BUTOXIDE; PYRETHRINS","strength":"4%;EQ 0.33% BASE","dosageForm":"AEROSOL;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/07\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21043lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RID MOUSSE","submission":"PIPERONYL BUTOXIDE; PYRETHRINS","actionType":"4%;EQ 0.33% BASE","submissionClassification":"AEROSOL;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-03-07
        )

)