NDA 020380

GALDERMA LABS LP

FDA Drug Application

Application #020380

Documents

• Label: 2017-03-30
• Letter: 2017-03-30
• Letter: 2017-05-24
• Label: 2017-05-25
• Review: 2017-10-02
• Label: 2018-03-28
• Letter: 2018-03-29
• Letter: 2022-06-15

Application Sponsors

NDA 020380

GALDERMA LABS LP

Marketing Status

• Over-the-counter: 002

Application Products

002

GEL;TOPICAL

0.1%

1

DIFFERIN

ADAPALENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2007-09-05	N/A
EFFICACY; Efficacy	SUPPL	10	AP	2016-07-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-05-19	STANDARD
LABELING; Labeling	SUPPL	13	AP	2018-03-23	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-06-14	STANDARD

Submissions Property Types

SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	13	Null	31
SUPPL	21	Null	7

CDER Filings

GALDERMA LABS LP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20380
            [companyName] => GALDERMA LABS LP
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIFFERIN","activeIngredients":"ADAPALENE","strength":"0.1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/23\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020380Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020380Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2016","submission":"SUPPL-10","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020380Orig1s010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DIFFERIN","submission":"ADAPALENE","actionType":"0.1%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-03-23
        )

)