NDA 021145

SKINMEDICA

FDA Drug Application

Application #021145

Documents

• Label: 2000-07-27
• Review: 2003-07-08
• Review: 2007-09-13
• Letter: 2000-07-27
• Review: 2007-09-13
• Review: 2007-09-13
• Review: 2007-09-13

Application Sponsors

NDA 021145

SKINMEDICA

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

13.9%

1

VANIQA

EFLORNITHINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2013-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-02-29	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

SKINMEDICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21145
            [companyName] => SKINMEDICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANIQA","activeIngredients":"EFLORNITHINE HYDROCHLORIDE","strength":"13.9%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/27\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21145lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VANIQA","submission":"EFLORNITHINE HYDROCHLORIDE","actionType":"13.9%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2000-07-27
        )

)