NDA 021908

SUCAMPO PHARMA LLC

FDA Drug Application

Application #021908

Documents

• Letter: 2008-05-05
• Letter: 2013-04-24
• Label: 2008-05-02
• Label: 2011-03-04
• Label: 2012-11-26
• Label: 2013-04-23
• Review: 2006-03-24
• Review: 2012-11-09
• Summary Review: 2008-07-17
• Letter: 2006-02-02
• Letter: 2007-05-29
• Letter: 2011-03-01
• Letter: 2012-11-28
• Label: 2006-02-02
• Label: 2007-05-29
• Review: 2010-05-03
• Review: 2013-08-06
• Review: 2015-08-21
• Letter: 2016-10-14
• Label: 2016-11-01
• Label: 2017-08-02
• Letter: 2017-08-02
• Label: 2018-04-27
• Letter: 2018-05-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-12-01
• Label: 2020-12-04

Application Sponsors

NDA 021908

SUCAMPO PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	24MCG	1	AMITIZA	LUBIPROSTONE
002	CAPSULE;ORAL	8MCG	1	AMITIZA	LUBIPROSTONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2006-01-31	STANDARD
LABELING; Labeling	SUPPL	4	AP	2007-05-16	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2008-04-29	UNKNOWN
LABELING; Labeling	SUPPL	8	AP	2011-02-24	STANDARD
LABELING; Labeling	SUPPL	10	AP	2012-11-26	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2013-04-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-08-19	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-10-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2017-08-01	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2018-04-26	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2020-11-30	STANDARD

Submissions Property Types

SUPPL	8	Null	6
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	0
SUPPL	13	Null	6
SUPPL	15	Null	15
SUPPL	16	Null	6
SUPPL	18	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SUCAMPO PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21908
            [companyName] => SUCAMPO PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMITIZA","activeIngredients":"LUBIPROSTONE","strength":"24MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AMITIZA","activeIngredients":"LUBIPROSTONE","strength":"8MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/30\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021908s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-16","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021908s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021908s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021908s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021908s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021908s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2011","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021908s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2008","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021908s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021908s004lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021908s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AMITIZA","submission":"LUBIPROSTONE","actionType":"24MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AMITIZA","submission":"LUBIPROSTONE","actionType":"8MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-11-30
        )

)