FDA.reportPublic FDA data

Application 212220

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIVAROXABANRIVAROXABANTABLET;ORAL2.5MGNoNo

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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XareltoRIVAROXABANJanssen Pharmaceuticals, Inc.10db92f9-2300-4a80-836b-673e1ae916102026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN
RIVAROXABANRIVAROXABANMicro Labs Limited481b7802-5093-43e7-bbd9-1532197eb6e62026-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RIVAROXABAN
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANNovadoz Pharmaceuticals LLCe8e4275c-6cbe-4976-8cae-f62baf954d272026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
XareltoRIVAROXABANCardinal Health 107, LLCd0e105f6-28f3-45ee-83bd-7d458835242b2026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANScieGen pharmaceuticals,Inc3b53cebf-946c-b82b-e063-6394a90a5da72026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANNorthStar RxLLC88246a0e-befe-4dc6-81e1-4b7adc266db22026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANSun Pharmaceutical Industries, Inc.925a9a11-ae5b-405c-96d2-b1be4b85bf712026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANAurobindo Pharma Limitedbcb0e6e7-3006-4d82-8009-c5fddbbfc80d2026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANDr.Reddy's Laboratories, Inc.122e6f78-067b-9065-adb2-ec7fec9f008e2026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANApotex Corp.e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd2026-04-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RIVAROXABANRIVAROXABANAlembic Pharmaceuticals Inc.e62f23c6-89f2-4179-95dc-5732401b3f932026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RIVAROXABAN
generic name: RIVAROXABAN
RIVAROXABANRIVAROXABANLupin Pharmaceuticals, Inc.702fed3e-ae25-49ba-98cc-562e0e2442142026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RIVAROXABAN
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANMacleods Pharmaceuticals Limited57717a31-d9d3-4246-90c0-4e4c0a29adf52026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
rivaroxabanRIVAROXABANChangzhou Pharmaceutical Factory9178947d-9d58-4c1a-b158-6030e17556af2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: rivaroxaban
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANIndoco Remedies Limited9fee7136-c8fd-4bea-ab15-7a0e7292396d2025-11-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RIVAROXABANRIVAROXABANAlembic Pharmaceuticals Limited5524f30f-789d-4f5c-8f7c-d03a475b6d342025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RIVAROXABAN
generic name: RIVAROXABAN
rivaroxabanRIVAROXABANFlorida Pharmaceutical Products, LLCf0ef9361-f06d-4028-97af-183b545f4aea2025-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: rivaroxaban
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANAscend Laboratories, LLCc0efa9f9-ca7a-471a-8030-99056fa5da092025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
RIVAROXABANRIVAROXABANXLCare Pharmaceuticals, Inc.291011aa-60eb-4109-b59c-1c521fbeac4f2025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RIVAROXABAN
generic name: RIVAROXABAN
RivaroxabanRIVAROXABANExelan pharmaceuticals,Incc2f55475-2a98-43f3-9eac-93995904ebc52025-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71681ORIG2022-08-01