NDA 020771

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020771

Documents

• Letter: 2001-04-06
• Letter: 2006-04-05
• Letter: 2009-04-16
• Letter: 2012-08-03
• Label: 1998-03-25
• Label: 2001-04-06
• Label: 2005-10-24
• Label: 2008-09-12
• Label: 2012-08-02
• Review: 2007-06-11
• Review: 2008-07-31
• Letter: 1998-03-25
• Letter: 2003-07-28
• Letter: 2004-01-14
• Letter: 2005-10-25
• Letter: 2007-03-23
• Letter: 2008-09-15
• Letter: 2011-09-23
• Label: 2009-04-16
• Label: 2011-09-23
• Review: 1998-03-25
• Review: 2008-08-04

Application Sponsors

NDA 020771

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	1MG	1	DETROL	TOLTERODINE TARTRATE
002	TABLET;ORAL	2MG	1	DETROL	TOLTERODINE TARTRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-05-26	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2001-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-11-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2000-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-07-20	STANDARD
LABELING; Labeling	SUPPL	10	AP	2003-07-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2004-01-05	STANDARD
LABELING; Labeling	SUPPL	13	AP	2005-10-17	STANDARD
LABELING; Labeling	SUPPL	14	AP	2006-03-24	STANDARD
LABELING; Labeling	SUPPL	17	AP	2007-03-16	STANDARD
LABELING; Labeling	SUPPL	19	AP	2008-09-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2009-04-08	STANDARD
LABELING; Labeling	SUPPL	24	AP	2011-09-20	STANDARD
LABELING; Labeling	SUPPL	28	AP	2012-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2014-07-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	24	Null	7
SUPPL	28	Null	15
SUPPL	29	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20771
            [companyName] => UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DETROL","activeIngredients":"TOLTERODINE TARTRATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DETROL","activeIngredients":"TOLTERODINE TARTRATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/01\/2012","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020771s028lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2011","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020771s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020771s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/11\/2008","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020771s019,021228s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020771s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2001","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20771s4lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20771lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DETROL","submission":"TOLTERODINE TARTRATE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DETROL","submission":"TOLTERODINE TARTRATE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-08-01
        )

)