Home Applications 020905 Application 020905
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARAVA LEFLUNOMIDE TABLET;ORAL 10MG Yes No 002 ARAVA LEFLUNOMIDE TABLET;ORAL 20MG Yes Yes 003 ARAVA LEFLUNOMIDE TABLET;ORAL 100MG Yes Yes
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 N020905-001 ARAVA LEFLUNOMIDE 10MG TABLET / ORAL AB RLD 1998-09-10 N020905-002 ARAVA LEFLUNOMIDE 20MG TABLET / ORAL AB RLD, RS 1998-09-10 N020905-003 ARAVA LEFLUNOMIDE 100MG TABLET / ORAL RLD 1998-09-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 4 · 126 observed 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 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020905-003 ARAVA 100MG TABLET / ORAL RLD 1998-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020905-002 ARAVA 20MG TABLET / ORAL AB RLD, RS 1998-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020905-003 ARAVA 100MG TABLET / ORAL RLD, RS 1998-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020905-001 ARAVA 10MG TABLET / ORAL AB RLD 1998-09-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 43 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2160 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2161 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0088-2162 Arava leflunomide sanofi-aventis U.S. LLC NDA Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA Current 0955-1735 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA Current 0955-1737 Leflunomide leflunomide Winthrop U.S. NDA AUTHORIZED GENERIC Current