Home Applications 216995 Application 216995
Type ANDA
Sponsor AIPING PHARM INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RIVAROXABAN RIVAROXABAN TABLET;ORAL 10MG No No 002 RIVAROXABAN RIVAROXABAN TABLET;ORAL 15MG No No 003 RIVAROXABAN RIVAROXABAN TABLET;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216995-001 RIVAROXABAN RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 A216995-002 RIVAROXABAN RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 A216995-003 RIVAROXABAN RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A216995-001 RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216995-002 RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216995-003 RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216995-001 RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216995-002 RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216995-003 RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216995-001 RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216995-002 RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216995-003 RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216995-001 RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216995-002 RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216995-003 RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216995-001 RIVAROXABAN 10MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216995-002 RIVAROXABAN 15MG TABLET / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216995-003 RIVAROXABAN 20MG TABLET / ORAL AB 2025-05-14 a50c72e98297…
Observed Orange Book normalized TE history# 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join rivaroxaban RIVAROXABAN Changzhou Pharmaceutical Factory 9178947d-9d58-4c1a-b158-6030e17556af 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216995 application number: ANDA216995