NDA 204708

GALDERMA LABS LP

FDA Drug Application

Application #204708

Documents

• Letter: 2013-08-27
• Letter: 2016-07-28
• Label: 2013-08-27
• Label: 2016-07-28
• Label: 2015-10-27
• Review: 2014-03-14
• Summary Review: 2014-03-14

Application Sponsors

NDA 204708

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

EQ 0.33% BASE

1

MIRVASO

BRIMONIDINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2013-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-09-23	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-07-27	901 REQUIRED

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

GALDERMA LABS LP

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            [labels] => [{"actionDate":"07\/27\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204708s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204708s003lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/23\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204708lbl.pdf\"}]","notes":""}]
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            [actionDate] => 2016-07-27
        )

)