FDA.reportPublic FDA data

Application 020771

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DETROLTOLTERODINE TARTRATETABLET;ORAL1MGYesNo
002DETROLTOLTERODINE TARTRATETABLET;ORAL2MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-4541Detroltolterodine tartratePharmacia & Upjohn Company LLCNDACurrent
0009-4541Detroltolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-4544Detroltolterodine tartratePharmacia & Upjohn Company LLCNDACurrent
0009-4544Detroltolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0093-2055Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-2056Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
59762-0170Tolterodine TartrateTolterodine TartrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0800Tolterodine TartrateTolterodine TartrateGreenstone LLCNDA AUTHORIZED GENERICCurrent
70518-1416Tolterodine TartrateTolterodine TartrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1416Tolterodine TartrateTolterodine TartrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1416Tolterodine TartrateTolterodine TartrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1416Tolterodine TartrateTolterodine TartrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1416Tolterodine TartrateTolterodine TartrateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
3311SUPPL2012-08-03
13393SUPPL2012-08-02
35314SUPPL2011-09-23
25765SUPPL2011-09-23
35313SUPPL2009-04-16
3310SUPPL2009-04-16
25764SUPPL2008-09-15
13392SUPPL2008-09-12
41686SUPPL2008-08-04
20929SUPPL2008-07-31
20928SUPPL2007-06-11
25763SUPPL2007-03-23
3309SUPPL2006-04-05
25762SUPPL2005-10-25
13391SUPPL2005-10-24
25761SUPPL2004-01-14
25760SUPPL2003-07-28
13390SUPPL2001-04-06
3308SUPPL2001-04-06
41685ORIG1998-03-25
25759ORIG1998-03-25
13389ORIG1998-03-25