NDA 022129

SHIONOGI INC

FDA Drug Application

Application #022129

Documents

• Letter: 2010-06-24
• Label: 2010-06-24
• Review: 2009-06-01
• Summary Review: 2009-06-01
• Letter: 2009-04-16
• Letter: 2012-07-17
• Label: 2009-04-16
• Label: 2012-07-30
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-04-27
• Label: 2020-04-27

Application Sponsors

NDA 022129

SHIONOGI INC

Marketing Status

• Discontinued: 001

Application Products

001

LOTION;TOPICAL

5%

1

ULESFIA

BENZYL ALCOHOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-04-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2010-06-22	UNKNOWN
LABELING; Labeling	SUPPL	5	AP	2012-07-12	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-03-24
LABELING; Labeling	SUPPL	8	AP	2020-04-26	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	6
SUPPL	5	Null	7
SUPPL	6	Null	0
SUPPL	8	Null	33

CDER Filings

SHIONOGI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22129
            [companyName] => SHIONOGI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULESFIA","activeIngredients":"BENZYL ALCOHOL","strength":"5%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/26\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022129s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022129s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022129s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/09\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022129lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ULESFIA","submission":"BENZYL ALCOHOL","actionType":"5%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-26
        )

)