NDA 021074

3M

FDA Drug Application

Application #021074

Documents

• Letter: 2001-10-02
• Letter: 2012-05-21
• Letter: 2012-06-11
• Letter: 2013-02-20
• Label: 2001-10-02
• Review: 2004-05-27
• Letter: 2015-11-16
• Label: 2014-01-14
• Label: 2015-11-13
• Letter: 2016-11-08
• Label: 2016-11-16
• Letter: 2017-09-08
• Label: 2017-09-08

Application Sponsors

NDA 021074

3M

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;TOPICAL

61%;1%

1

AVAGARD

ALCOHOL; CHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-06-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2012-05-17	STANDARD
LABELING; Labeling	SUPPL	8	AP	2012-06-07	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2013-02-15	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-11-12	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-11-04	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-09-06	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	6
SUPPL	12	Null	6

CDER Filings

3M

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21074
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"AVAGARD","activeIngredients":"ALCOHOL; CHLORHEXIDINE GLUCONATE","strength":"61%;1%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/06\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021074Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021074Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021074Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/21074Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21-074_Avagard_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AVAGARD","submission":"ALCOHOL; CHLORHEXIDINE GLUCONATE","actionType":"61%;1%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-09-06
        )

)