NDA 022502

GALDERMA LABS LP

FDA Drug Application

Application #022502

Documents

• Letter: 2010-03-22
• Label: 2013-04-23
• Review: 2010-08-30
• Summary Review: 2010-08-30
• Letter: 2013-04-23
• Label: 2010-03-18
• Pediatric Statistical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Label: 2022-08-29

Application Sponsors

NDA 022502

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.1%

1

DIFFERIN

ADAPALENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-03-17	STANDARD
LABELING; Labeling	SUPPL	3	AP	2013-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2014-09-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-08-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	6

CDER Filings

GALDERMA LABS LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22502
            [companyName] => GALDERMA LABS LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIFFERIN","activeIngredients":"ADAPALENE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/24\/2022","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/022502s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022502s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022502lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DIFFERIN","submission":"ADAPALENE","actionType":"0.1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-08-24
        )

)