FDA.reportPublic FDA data

Application 021595

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SANCTURATROSPIUM CHLORIDETABLET;ORAL20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021595-001SANCTURATROSPIUM CHLORIDE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-05-28

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021595-001SANCTURA20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-05-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021595-001SANCTURA20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-05-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021595-001SANCTURA20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-05-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021595-001SANCTURA20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-05-28a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trospium ChlorideTROSPIUM CHLORIDEMAJOR PHARMACEUTICALS7a2fea88-266d-4fc0-a476-66dc6effcff72026-09-03Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDESlate Run Pharmaceuticals, LLCc1c8bd8b-7ff8-5940-e053-2995a90ae6562026-08-05Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium ChlorideTROSPIUM CHLORIDEREMEDYREPACK INC.48d1b484-ee0a-4d66-9b45-4ba34e65ed132026-04-23Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDEBryant Ranch Prepack095f54ba-4d43-4266-8942-eede6678ee3b2026-04-14Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium ChlorideTROSPIUM CHLORIDEGlenmark Pharmaceuticals Inc., USAd5c837a4-d1c6-4615-b7ad-27f3162a03aa2025-12-30Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDEChartwell RX, LLC801f2143-6816-4f34-b65d-16bb2cf079752025-12-11Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium ChlorideTROSPIUM CHLORIDEGolden State Medical Supply, Inc.8e5e2b3a-467b-4312-9778-8ff2ce9388382025-12-11Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium Chloride ERTROSPIUM CHLORIDEBryant Ranch Prepackc0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e12025-10-21Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDEBryant Ranch Prepack832d1e92-1024-495a-bb7f-590412aae6992025-10-21Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDEPD-Rx Pharmaceuticals, Inc.6303cf3c-175c-46ff-9b88-05f6ea7a21352025-10-09Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium ChlorideTROSPIUM CHLORIDEMajor Pharmaceuticals35ae4d64-4625-4fdd-a2d4-e20b87c568762025-07-21Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium ChlorideTROSPIUM CHLORIDEZameer Pharmaceuticals LLC048b4bc7-c77e-40fc-9bfb-bb35c6a3f8712024-12-19Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium ChlorideTROSPIUM CHLORIDEMacleods Pharmaceuticals Limitedfcb13b21-e4a2-461b-b3cb-0daedc7220502024-09-03Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium Chloride ERTROSPIUM CHLORIDEBryant Ranch Prepackdfc1af0b-b0e7-43fd-8da0-65281963bc3e2024-07-16Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium ChlorideTROSPIUM CHLORIDEAphena Pharma Solutions - Tennessee, LLC1523cb4c-3a52-6c18-e063-6394a90a396f2024-04-02Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDEBryant Ranch Prepack871d70aa-4a7d-44dd-933c-969164b759422023-11-07Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium Chloride ERTROSPIUM CHLORIDEBryant Ranch Prepack2f431dd1-e130-45e5-a796-1662f498585e2023-11-06Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDEBryant Ranch Prepack1065cfd9-3d32-466c-8dff-c81eae1a05332023-10-23Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
TROSPIUM CHLORIDETROSPIUM CHLORIDEPadagis US LLCbb3284ee-3d13-41c7-8e4b-f9b2d44350da2023-04-30Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE
Trospium Chloride ERTROSPIUM CHLORIDEPadagis US LLC4574f905-a8c5-4732-b934-d1c7f9e708c92022-11-30Warnings, Adverse reactionsName fallback
generic name: TROSPIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
28220SUPPL2012-07-25
5818SUPPL2012-07-25
37312SUPPL2012-07-24
15850SUPPL2012-07-24
37310SUPPL2011-09-30
28218SUPPL2011-09-28
37311SUPPL2011-02-09
28219SUPPL2011-02-04
15849SUPPL2009-06-04
28217SUPPL2006-12-28
28216SUPPL2006-09-15
37309SUPPL2006-09-12
28215SUPPL2005-03-14
15848SUPPL2005-03-14
42226ORIG2004-07-08
15847ORIG2004-06-01
5817ORIG2004-06-01