NDA 017577

JANSSEN PHARMS

FDA Drug Application

Application #017577

Documents

• Letter: 2009-07-16
• Letter: 2012-03-26
• Label: 2003-04-16
• Label: 2008-02-14
• Label: 2009-07-23
• Label: 2011-08-08
• Label: 2011-12-20
• Label: 2012-03-23
• Letter: 2003-05-29
• Letter: 2008-02-13
• Letter: 2011-08-10
• Letter: 2011-12-20
• Review: 2009-09-14
• Label: 2003-04-16
• Review: 2009-09-14

Application Sponsors

NDA 017577

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

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5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
        )

)