NDA 022563

MAYNE PHARMA

FDA Drug Application

Application #022563

Documents

• Letter: 2010-10-13
• Letter: 2011-04-25
• Label: 2011-04-22
• Label: 2012-09-28
• Summary Review: 2011-05-03
• Letter: 2012-10-02
• Label: 2010-10-12
• Review: 2011-05-03
• Label: 2019-05-07
• Letter: 2019-11-08
• Letter: 2019-11-08
• Pediatric Other: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 022563

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

0.005%

1

SORILUX

CALCIPOTRIENE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2010-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2012-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-07-10	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2019-05-06	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2019-11-05	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-05	STANDARD

Submissions Property Types

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

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22563
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORILUX","activeIngredients":"CALCIPOTRIENE","strength":"0.005%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/06\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022563s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2012","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022563s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2011","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022563s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022563s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SORILUX","submission":"CALCIPOTRIENE","actionType":"0.005%","submissionClassification":"AEROSOL, FOAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-06
        )

)