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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020771-001DETROLTOLTERODINE TARTRATE1MGTABLET / ORALABRLD1998-03-25
N020771-002DETROLTOLTERODINE TARTRATE2MGTABLET / ORALABRLD, RS1998-03-25

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
N020771-001AB
N020771-002AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine TartrateTOLTERODINE TARTRATEMylan Pharmaceuticals Inc.9e432622-2e6f-4cf8-892f-510288dd50f22024-09-21Warnings, Adverse reactionsExact identifier
DetrolTOLTERODINE TARTRATEViatris Specialty LLC41eb00d2-64e3-4ec9-8732-4bfc81b041802023-02-15Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate tablets. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate tablets should be discontinued and appropriate therapy promptly provided.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS The Phase 2 and 3 clinical trial program for tolterodine tartrate tablets included 3071 patients who were treated with tolterodine tartrate tablets (N=2133) or placebo (N=938). The patients were treated with 1, 2, 4, or 8 mg/day for up to 12 months. No differences in the safety profile of tolterodine were identified based on age, gender, race, or metabolism. The data described below reflect exposure to tolterodine tartrate tablets 2 mg bid in 986 patients and to placebo in 683 patients exposed for 12 weeks in five Phase 3, controlled clinical studies. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and approximating rates. Sixty-six percent of patients receiving tolterodine tartrate tablets 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving tolterodine tartrate tablets were dry mouth, headache, constipation, vertigo/dizziness, and abdominal pain. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and xerophthalmia are expected side effects of antimuscarinic agents. Dry mouth was the most frequently reported adverse event for patients treated with tolterodine tartrate tablets 2 mg bid in the Phase 3 clinical studies, occurring in 34.8% of patients treated with tolterodine tartrate tablets and 9.8% of placebo-treated patients. One percent of patients treated with tolterodine tartrate tablets discontinued treatment due to dry mouth. The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Seven percent of patients treated with tolterodine tartrate tablets 2 mg bid discontinued treatment due to adverse events versus 6% of placebo patients. The most common adverse events leading to discontinuation of tolterodine tartrate tablets were dizziness and headache. Three percent of patients treated with tolterodine tartrate tablets 2 mg bid reported a serious adverse event versus 4% of placebo patients. Significant ECG ch...

adverse reactions table

Table 5. Incidencein nearest integer. (%) of Adverse Events Exceeding Placebo Rate and Reported in >1% of Patients Treated with Tolterodine TartrateTablets (2 mg bid) in 12-week, Phase 3 Clinical StudiesBody SystemAdverse Event% Tolterodine TartrateTabletsN=986% PlaceboN=683Autonomic Nervousaccommodation abnormal21dry mouth 3510Generalchest pain21fatigue43headache75influenza-like symptoms 32Central/Peripheral Nervous vertigo/dizziness53Gastrointestinalabdominal pain53constipation74diarrhea43dyspepsia 41Urinarydysuria 21Skin/Appendagesdry skin 10Musculoskeletalarthralgia 21Visionxerophthalmia 32Psychiatricsomnolence 32Metabolic/Nutritionalweight gain 10Resistance Mechanisminfection 10

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