NDA 021794

ALLERGAN

FDA Drug Application

Application #021794

Documents

• Letter: 2005-07-15
• Letter: 2008-03-18
• Review: 2007-09-13
• Letter: 2015-07-13
• Label: 2005-07-08
• Label: 2008-03-17
• Label: 2009-04-03
• Label: 2015-07-24
• Letter: 2018-05-21
• Label: 2018-05-22

Application Sponsors

NDA 021794

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

5%

1

ACZONE

DAPSONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-07-07	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2008-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2009-03-26	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2013-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2013-10-03	STANDARD
LABELING; Labeling	SUPPL	12	AP	2013-11-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2015-09-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-05-18	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	6
SUPPL	14	Null	0
SUPPL	16	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21794
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACZONE","activeIngredients":"DAPSONE","strength":"5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/18\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021794s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021794s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021794s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2009","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021794s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2009","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021794s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2008","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021794s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/07\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021794lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACZONE","submission":"DAPSONE","actionType":"5%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-18
        )

)