ALLERGAN FDA Approval NDA 022103

NDA 022103

ALLERGAN

FDA Drug Application

Application #022103

Documents

Letter2007-08-07
Letter2011-09-16
Letter2011-02-04
Review2008-07-11
Letter2012-08-20
Label2009-06-04
Label2011-09-16
Label2011-01-31
Label2012-08-20

Application Sponsors

NDA 022103ALLERGAN

Marketing Status

Discontinued001

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1SANCTURA XRTROSPIUM CHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2007-08-03STANDARD
LABELING; LabelingSUPPL2AP2009-06-01STANDARD
LABELING; LabelingSUPPL3AP2011-09-14STANDARD
LABELING; LabelingSUPPL4AP2011-01-31STANDARD
LABELING; LabelingSUPPL5AP2012-08-17STANDARD

Submissions Property Types

SUPPL3Null15
SUPPL4Null6
SUPPL5Null6

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CHLORIDE","strength":"60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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
        )

)

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