NDA 022320

GALDERMA LABS LP

FDA Drug Application

Application #022320

Documents

• Letter: 2008-12-19
• Letter: 2011-12-20
• Letter: 2013-02-04
• Summary Review: 2010-01-13
• Letter: 2011-02-24
• Label: 2009-01-02
• Label: 2011-02-24
• Label: 2011-12-20
• Label: 2013-02-06
• Review: 2010-01-13
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Review: 2019-02-15
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 022320

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.1%;2.5%

1

EPIDUO

ADAPALENE; BENZOYL PEROXIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2008-12-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2011-12-14	UNKNOWN
EFFICACY; Efficacy	SUPPL	4	AP	2013-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2014-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-08-01	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

TE Codes

001

Prescription

AB

CDER Filings

GALDERMA LABS LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22320
            [companyName] => GALDERMA LABS LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPIDUO","activeIngredients":"ADAPALENE; BENZOYL PEROXIDE","strength":"0.1%;2.5%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/01\/2013","submission":"SUPPL-4","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022320s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2011","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022320s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2011","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022320s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022320lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EPIDUO","submission":"ADAPALENE; BENZOYL PEROXIDE","actionType":"0.1%;2.5%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-02-01
        )

)