NDA 021307

BAYER HEALTHCARE LLC

FDA Drug Application

Application #021307

Documents

• Letter: 2001-12-07
• Letter: 2006-04-07
• Letter: 2012-05-04
• Letter: 2015-12-22
• Label: 2015-12-22
• Review: 2002-03-26
• Letter: 2011-04-04
• Letter: 2014-12-18
• Label: 2001-12-07
• Letter: 2020-12-23
• Label: 2020-12-23
• Letter: 2021-10-20
• Label: 2021-12-13

Application Sponsors

NDA 021307

BAYER HEALTHCARE LLC

Marketing Status

• Over-the-counter: 001

Application Products

001

CREAM;TOPICAL

1%

1

LOTRIMIN ULTRA

BUTENAFINE HYDROCHLORIDE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC Switch	ORIG	1	AP	2001-12-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	2006-04-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	2011-03-31	STANDARD
LABELING; Labeling	SUPPL	13	AP	2012-05-02	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2014-12-17	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2017-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2020-12-15	N/A
LABELING; Labeling	SUPPL	19	AP	2021-10-18	STANDARD

Submissions Property Types

SUPPL	12	Null	6
SUPPL	13	Null	6
SUPPL	14	Null	7
SUPPL	15	Null	7
SUPPL	18	Null	6
SUPPL	19	Null	6

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21307
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTRIMIN ULTRA","activeIngredients":"BUTENAFINE HYDROCHLORIDE","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/18\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021307Orig1s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/07\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21307lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOTRIMIN ULTRA","submission":"BUTENAFINE HYDROCHLORIDE","actionType":"1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-12-18
        )

)