FDA.reportPublic FDA data

Application 208549

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIVAROXABANRIVAROXABANTABLET;ORAL10MGNoNo
002RIVAROXABANRIVAROXABANTABLET;ORAL15MGNoNo
003RIVAROXABANRIVAROXABANTABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIVAROXABANRIVAROXABANCamber Pharmaceuticals, Inc.45f16f1b-e405-4aa6-bc8b-977d4864af3e2025-05-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RIVAROXABAN
generic name: RIVAROXABAN
XareltoRIVAROXABANA-S Medication Solutionse76bf2cf-a8b8-4471-a8ce-57c918b11a482024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN
XareltoRIVAROXABANA-S Medication Solutions65727928-9421-4df8-bff2-f72a9cc780692024-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN
XareltoRIVAROXABANA-S Medication Solutions7e9ab975-db2f-423c-a089-bc5a733136092024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN
XARELTORIVAROXABANA-S Medication Solutions3e95389b-0a93-4560-98c5-02637fb2600f2023-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN
XareltoRIVAROXABANAphena Pharma Solutions - Tennessee, LLC38b11f5d-f0fc-46dc-aef1-ea31872bb6212023-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN

Reported adverse events (FAERS/openFDA)#

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