FDA.reportPublic FDA data

Application 021228

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DETROL LATOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL2MGYesNo
002DETROL LATOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL4MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021228-001DETROL LATOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALABRLD2000-12-22
N021228-002DETROL LATOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS2000-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021228-001AB
N021228-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021228-001DETROL LA2MGCAPSULE, EXTENDED RELEASE / ORALABRLD2000-12-22a50c72e98297…
2026-08-01 22:54:322026-06N021228-002DETROL LA4MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS2000-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021228-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021228-002AB1a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine TartrateTOLTERODINE TARTRATEMajor Pharmaceuticalse4b9ef09-c750-4e35-96fc-e759ba4849d82026-06-24Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATEA-S Medication Solutionsfd6c8b3d-a52a-4418-aa9c-0297db6c08072026-01-09Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATEGolden State Medical Supply, Inc.05b92da2-923b-3c04-e063-6394a90a69a12026-01-06Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATESlate Run Pharmaceuticals, LLCbbbee85a-e5e2-24ec-e053-2995a90acfd82025-12-01Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine tartrateTOLTERODINE TARTRATEAjanta Pharma USA Inc.fcaca033-cd08-4b8c-9bad-7b6751faf2c92025-11-03Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATEANI Pharmaceuticals, Inc.fc5bdc4a-a483-4d31-807b-c7f8d88697232025-04-01Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATERising Pharma Holdings, Inc.b9ba8ad2-27f6-4f18-bd84-73659047910e2025-04-01Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATETeva Pharmaceuticals USA, Inc.973f98b5-4e8a-42d9-ac69-d4333d21c3622024-09-25Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATEMylan Pharmaceuticals Inc.9e432622-2e6f-4cf8-892f-510288dd50f22024-09-21Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine tartrateTOLTERODINE TARTRATEUnichem Pharmaceuticals (USA), Inc.9710ad7b-93c2-4ec1-95ff-597563be43142024-09-03Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
DetrolTOLTERODINE TARTRATEViatris Specialty LLC41eb00d2-64e3-4ec9-8732-4bfc81b041802023-02-15Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine tartrateTOLTERODINE TARTRATEMacleods Pharmaceuticals Limited3f2291c3-7e3c-41be-afa6-ef73ce896e302022-11-19Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATETeva Pharmaceuticals USA, Inc.d27e25b5-5d02-419f-b098-41fb162c58722022-10-11Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATECamber Pharmaceuticals, Inc.f67fce7c-69d3-42ae-8c1d-2e26fd4d74152021-08-16Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATEUnichem Pharmaceuticals (USA), Inc.56e62829-5371-416a-90b3-4b6429532d252020-08-07Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATEProficient Rx LPb77f9893-a422-423a-bb27-527377ade36d2019-10-01Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE
Tolterodine TartrateTOLTERODINE TARTRATECamber Pharmaceuticals, Inc.e16012ae-5972-470b-8a22-b0626a029e952017-06-03Warnings, Adverse reactionsName fallback
generic name: TOLTERODINE TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-5190Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5190Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5190Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5191Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5191Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0009-5191Detrol LAtolterodine tartratePharmacia and Upjohn Company LLCNDACurrent
0093-2049Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-2050Tolterodine TartrateTolterodine TartrateTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
55154-3933Detrol LAtolterodine tartrateCardinal HealthNDACurrent
55154-3935Detrol LAtolterodine tartrateCardinal HealthNDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-132Detrol LAtolterodine tartratePD-Rx Pharmaceuticals, Inc.NDACurrent
59762-0047Tolterodine Tartrate Extended Releasetolterodine tartrateGreenstone LLCNDACurrent
59762-0048Tolterodine Tartrate Extended Releasetolterodine tartrateGreenstone LLCNDACurrent
68151-4247Tolterodine TartrateTolterodine TartrateCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68151-4281Tolterodine TartrateTolterodine TartrateCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
69189-5190Detrol LAtolterodine tartrateAvera McKennan HospitalNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54929SUPPL2018-07-20
54920SUPPL2018-07-19
47866SUPPL2017-04-05
4707SUPPL2012-08-03
14682SUPPL2012-08-02
36419SUPPL2011-09-23
4706SUPPL2011-09-23
36418SUPPL2010-01-08
27140SUPPL2010-01-06
4705SUPPL2008-09-15
42042SUPPL2007-06-11
42041SUPPL2007-06-11
42040SUPPL2007-06-11
21527SUPPL2007-06-11
4704SUPPL2007-03-23
14681SUPPL2005-10-25
4703SUPPL2005-10-25
36417SUPPL2005-07-21
27139SUPPL2005-07-21
36416SUPPL2004-05-03
27138SUPPL2004-04-20
21526ORIG2004-02-11
4702SUPPL2004-01-22
27137SUPPL2003-07-28
14680SUPPL2003-05-01
36415ORIG2000-12-22
4701ORIG2000-12-22
53140ORIG1900-01-01
53139ORIG1900-01-01
53138ORIG1900-01-01
53137ORIG1900-01-01
53136ORIG1900-01-01
53135ORIG1900-01-01
53134ORIG1900-01-01
53133ORIG1900-01-01