NDA 021252

ALLERGAN

FDA Drug Application

Application #021252

Documents

• Letter: 2001-01-05
• Letter: 2003-10-17
• Letter: 2004-11-08
• Letter: 2004-09-29
• Letter: 2006-06-12
• Label: 2013-02-08
• Label: 2013-12-19
• Review: 2001-01-05
• Letter: 2008-05-28
• Letter: 2013-02-07
• Letter: 2013-12-20
• Label: 2003-04-08
• Label: 2004-11-08
• Label: 2016-09-02
• Letter: 2016-09-02
• Label: 2017-07-31
• Letter: 2017-08-02
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-10-02
• Label: 2020-10-07
• Letter: 2021-11-02
• Label: 2021-11-02
• Letter: 2022-11-17
• Label: 2022-11-17

Application Sponsors

NDA 021252

ALLERGAN

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	SUPPOSITORY;RECTAL	500MG	0	CANASA	MESALAMINE
002	SUPPOSITORY;RECTAL	1GM	1	CANASA	MESALAMINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2001-01-05	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2003-10-14	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2004-11-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2004-09-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2008-05-23	N/A
LABELING; Labeling	SUPPL	13	AP	2013-02-06	UNKNOWN
EFFICACY; Efficacy	SUPPL	14	AP	2016-09-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-05-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2013-12-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2014-01-02	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2013-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-07-30	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2017-07-27	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-10-01	STANDARD
LABELING; Labeling	SUPPL	28	AP	2021-11-01	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	7	Null	31
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	6
SUPPL	21	Null	0
SUPPL	23	Null	15
SUPPL	25	Null	7
SUPPL	28	Null	6
SUPPL	29	Null	6

TE Codes

002

Prescription

AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21252
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANASA","activeIngredients":"MESALAMINE","strength":"500MG","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CANASA","activeIngredients":"MESALAMINE","strength":"1GM","dosageForm":"SUPPOSITORY;RECTAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/27\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021252s023lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2016","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021252s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021252s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021252s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2004","submission":"SUPPL-5","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21252s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/05\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21252lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CANASA","submission":"MESALAMINE","actionType":"500MG","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CANASA","submission":"MESALAMINE","actionType":"1GM","submissionClassification":"SUPPOSITORY;RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-27
        )

)