NDA 022555

PHOTOCURE ASA

FDA Drug Application

Application #022555

Documents

• Label: 2010-06-03
• Label: 2016-08-02
• Review: 2011-07-20
• Summary Review: 2011-07-20
• Letter: 2010-06-08
• Label: 2018-02-16
• Letter: 2018-02-23

Application Sponsors

NDA 022555

PHOTOCURE ASA

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;INTRAVESICAL

100MG/VIAL

1

CYSVIEW KIT

HEXAMINOLEVULINATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-05-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2012-11-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2016-07-29	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2018-02-15	PRIORITY

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	15

CDER Filings

PHOTOCURE ASA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22555
            [companyName] => PHOTOCURE ASA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYSVIEW KIT","activeIngredients":"HEXAMINOLEVULINATE HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"FOR SOLUTION;INTRAVESICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/15\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022555s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022555s004lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/28\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022555s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CYSVIEW KIT","submission":"HEXAMINOLEVULINATE HYDROCHLORIDE","actionType":"100MG\/VIAL","submissionClassification":"FOR SOLUTION;INTRAVESICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-02-15
        )

)