FDA.reportPublic FDA data

Application 213348

Type
ANDA
Sponsor
SUNSHINE

Application Products#

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213348-001RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-14
A213348-002RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-14
A213348-003RIVAROXABANRIVAROXABAN20MGTABLET / ORALAB2025-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A213348-001AB
A213348-002AB
A213348-003AB

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
2026-02-19 14:30 UTC2026-02A213348-001RIVAROXABAN10MGTABLET / ORALAB2025-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213348-002RIVAROXABAN15MGTABLET / ORALAB2025-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213348-003RIVAROXABAN20MGTABLET / ORALAB2025-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213348-001RIVAROXABAN10MGTABLET / ORALAB2025-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213348-002RIVAROXABAN15MGTABLET / ORALAB2025-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213348-003RIVAROXABAN20MGTABLET / ORALAB2025-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A213348-001RIVAROXABAN10MGTABLET / ORALAB2025-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213348-002RIVAROXABAN15MGTABLET / ORALAB2025-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213348-003RIVAROXABAN20MGTABLET / ORALAB2025-05-146a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213348-001RIVAROXABAN10MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213348-002RIVAROXABAN15MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213348-003RIVAROXABAN20MGTABLET / ORALAB2025-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213348-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213348-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213348-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213348-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213348-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213348-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213348-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213348-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213348-003AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213348-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213348-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213348-003AB1a50c72e98297…

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
RIVAROXABANRIVAROXABANMicro Labs Limited481b7802-5093-43e7-bbd9-1532197eb6e62026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: RIVAROXABAN
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
RivaroxabanRIVAROXABANNovadoz Pharmaceuticals LLCe8e4275c-6cbe-4976-8cae-f62baf954d272026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Rivaroxaban
generic name: RIVAROXABAN
XareltoRIVAROXABANCardinal Health 107, LLCd0e105f6-28f3-45ee-83bd-7d458835242b2026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RIVAROXABAN
XareltoRIVAROXABANJanssen Pharmaceuticals, Inc.10db92f9-2300-4a80-836b-673e1ae916102026-01-16Boxed warning, Warnings, Adverse reactionsName fallback
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