JANSSEN PHARMS FDA Approval NDA 020897

NDA 020897

JANSSEN PHARMS

FDA Drug Application

Application #020897

Documents

Letter2003-05-29
Letter2008-03-17
Letter2011-07-05
Letter2012-03-27
Letter2015-03-02
Label2003-04-16
Label2008-02-14
Label2009-07-23
Label2011-06-30
Label2012-11-15
Review1998-12-16
Letter1998-12-16
Letter2004-06-30
Letter2009-07-17
Letter2011-12-20
Letter2012-11-14
Letter2013-08-05
Label1998-12-16
Label2003-04-16
Label2004-07-01
Label2011-12-20
Label2012-03-27
Label2013-08-09
Label2015-03-04
Review2007-04-11
Letter2016-09-15
Label2016-09-28
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Written Request1900-01-01
Letter2018-10-29
Label2018-11-06
Letter2019-09-13
Label2019-09-13
Label2021-03-30
Letter2021-03-30

Application Sponsors

NDA 020897JANSSEN PHARMS

Marketing Status

Prescription001
Prescription002
Discontinued003

Application Products

001TABLET, EXTENDED RELEASE;ORAL5MG1DITROPAN XLOXYBUTYNIN CHLORIDE
002TABLET, EXTENDED RELEASE;ORAL10MG1DITROPAN XLOXYBUTYNIN CHLORIDE
003TABLET, EXTENDED RELEASE;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1DITROPAN XLOXYBUTYNIN CHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1998-12-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-06-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1999-05-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-06-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-09-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-07-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-09-29STANDARD
LABELING; LabelingSUPPL8AP2000-04-17STANDARD
EFFICACY; EfficacySUPPL9AP2003-04-15STANDARD
LABELING; LabelingSUPPL10AP2003-04-15STANDARD
EFFICACY; EfficacySUPPL13AP2004-06-30STANDARD
LABELING; LabelingSUPPL18AP2008-02-06STANDARD
LABELING; LabelingSUPPL24AP2009-07-13STANDARD
LABELING; LabelingSUPPL28AP2011-06-28UNKNOWN
LABELING; LabelingSUPPL29AP2011-12-15UNKNOWN
LABELING; LabelingSUPPL30AP2012-03-23STANDARD
LABELING; LabelingSUPPL31AP2012-11-13STANDARD
LABELING; LabelingSUPPL32AP2013-08-01STANDARD
LABELING; LabelingSUPPL33AP2015-02-27STANDARD
LABELING; LabelingSUPPL35AP2016-09-13STANDARD
LABELING; LabelingSUPPL36AP2018-10-26STANDARD
LABELING; LabelingSUPPL37AP2019-09-12STANDARD
LABELING; LabelingSUPPL38AP2021-03-29STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null8
SUPPL28Null6
SUPPL29Null6
SUPPL30Null6
SUPPL31Null6
SUPPL32Null7
SUPPL33Null7
SUPPL35Null7
SUPPL36Null15
SUPPL37Null6
SUPPL38Null6

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

JANSSEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20897
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DITROPAN XL","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DITROPAN XL","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DITROPAN XL","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/29\/2021","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020897s038lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2019","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020897s037lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020897s036lbledt.pdf\"}]","notes":""},{"actionDate":"09\/13\/2016","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020897s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020897s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020897s032lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020897s031lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2012","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020897s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2011","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020897s029lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2011","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020897s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2009","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020897s024lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2008","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017577s034,018211s017,020897s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2004","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20897se8-013_Ditropan_lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2003","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2003","submission":"SUPPL-9","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20897lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DITROPAN XL","submission":"OXYBUTYNIN CHLORIDE","actionType":"5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DITROPAN XL","submission":"OXYBUTYNIN CHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DITROPAN XL","submission":"OXYBUTYNIN CHLORIDE","actionType":"15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-03-29
        )

)
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