Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Discontinued | 003 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 5MG | 1 | DITROPAN XL | OXYBUTYNIN CHLORIDE |
002 | TABLET, EXTENDED RELEASE;ORAL | 10MG | 1 | DITROPAN XL | OXYBUTYNIN CHLORIDE |
003 | TABLET, EXTENDED RELEASE;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DITROPAN XL | OXYBUTYNIN CHLORIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-12-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-06-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1999-05-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-06-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-09-28 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-07-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-09-29 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2000-04-17 | STANDARD |
EFFICACY; Efficacy | SUPPL | 9 | AP | 2003-04-15 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2003-04-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 13 | AP | 2004-06-30 | STANDARD |
LABELING; Labeling | SUPPL | 18 | AP | 2008-02-06 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2009-07-13 | STANDARD |
LABELING; Labeling | SUPPL | 28 | AP | 2011-06-28 | UNKNOWN |
LABELING; Labeling | SUPPL | 29 | AP | 2011-12-15 | UNKNOWN |
LABELING; Labeling | SUPPL | 30 | AP | 2012-03-23 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2012-11-13 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 2013-08-01 | STANDARD |
LABELING; Labeling | SUPPL | 33 | AP | 2015-02-27 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2016-09-13 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2018-10-26 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2019-09-12 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2021-03-29 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 8 |
SUPPL | 28 | Null | 6 |
SUPPL | 29 | Null | 6 |
SUPPL | 30 | Null | 6 |
SUPPL | 31 | Null | 6 |
SUPPL | 32 | Null | 7 |
SUPPL | 33 | Null | 7 |
SUPPL | 35 | Null | 7 |
SUPPL | 36 | Null | 15 |
SUPPL | 37 | Null | 6 |
SUPPL | 38 | Null | 6 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
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
)
)