NDA 022103

ALLERGAN

FDA Drug Application

Application #022103

Documents

• Letter: 2007-08-07
• Letter: 2011-09-16
• Letter: 2011-02-04
• Review: 2008-07-11
• Letter: 2012-08-20
• Label: 2009-06-04
• Label: 2011-09-16
• Label: 2011-01-31
• Label: 2012-08-20

Application Sponsors

NDA 022103

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

SANCTURA XR

TROSPIUM CHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2007-08-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	2009-06-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2011-09-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2011-01-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	2012-08-17	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	4	Null	6
SUPPL	5	Null	6

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22103
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SANCTURA XR","activeIngredients":"TROSPIUM CHLORIDE","strength":"60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/17\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022103s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2011","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022103s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2011","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022103s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/01\/2009","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022103s002lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SANCTURA XR","submission":"TROSPIUM CHLORIDE","actionType":"60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-08-17
        )

)