Documents
Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DITROPAN | OXYBUTYNIN CHLORIDE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1975-07-16 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1976-04-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1977-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 1976-10-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1977-04-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1977-12-05 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 1979-06-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1980-12-22 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 1982-09-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1983-01-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1983-01-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1983-01-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1985-06-19 | STANDARD |
LABELING; Labeling | SUPPL | 16 | AP | 1986-06-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1986-08-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1986-10-23 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 1988-02-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1988-04-29 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 1989-02-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1990-11-27 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 1991-03-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1991-12-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1996-05-31 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1996-07-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1997-11-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1998-02-20 | STANDARD |
EFFICACY; Efficacy | SUPPL | 32 | AP | 2003-04-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 33 | AP | 2003-04-15 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 2008-02-06 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2009-07-13 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 2011-08-08 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 2011-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 2012-03-22 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 21 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 0 |
SUPPL | 30 | Null | 0 |
SUPPL | 32 | Null | 0 |
SUPPL | 33 | Null | 0 |
SUPPL | 34 | Null | 0 |
SUPPL | 35 | Null | 0 |
SUPPL | 36 | Null | 0 |
SUPPL | 37 | Null | 0 |
SUPPL | 38 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 17577
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DITROPAN","activeIngredients":"OXYBUTYNIN CHLORIDE","strength":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/22\/2012","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/017577s038lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2011","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/017577s037lbl.pdf\"}]","notes":""},{"actionDate":"08\/08\/2011","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/017577s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2009","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/017577s035lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2008","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017577s034,018211s017,020897s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2003","submission":"SUPPL-33","supplementCategories":"Efficacy-Labeling Change With Clinical Data","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-32","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DITROPAN","submission":"OXYBUTYNIN CHLORIDE","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-03-22
)
)