NDA 022206

ALLERGAN

FDA Drug Application

Application #022206

Documents

• Letter: 2008-10-14
• Letter: 2012-12-19
• Letter: 2013-07-15
• Label: 2009-02-20
• Label: 2010-03-05
• Label: 2012-12-18
• Letter: 2009-02-18
• Letter: 2010-03-08
• Label: 2008-11-07
• Label: 2013-07-17
• Review: 2008-11-14
• Summary Review: 2008-11-17
• Letter: 2020-12-16
• Label: 2020-12-17

Application Sponsors

NDA 022206

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	4MG	1	RAPAFLO	SILODOSIN
002	CAPSULE;ORAL	8MG	1	RAPAFLO	SILODOSIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-10-08	STANDARD
LABELING; Labeling	SUPPL	6	AP	2010-03-04	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2012-12-14	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2013-06-24	STANDARD
LABELING; Labeling	SUPPL	12	AP	2013-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2013-11-08	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-12-15	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	6	Null	6
SUPPL	8	Null	15
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	0
SUPPL	16	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22206
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAPAFLO","activeIngredients":"SILODOSIN","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"RAPAFLO","activeIngredients":"SILODOSIN","strength":"8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/12\/2013","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022206s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2012","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022206s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2010","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022206s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022206s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2009","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022206s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022206lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RAPAFLO","submission":"SILODOSIN","actionType":"4MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RAPAFLO","submission":"SILODOSIN","actionType":"8MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-07-12
        )

)