Home Applications 022425 Application 022425
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MULTAQ DRONEDARONE HYDROCHLORIDE TABLET;ORAL EQ 400MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022425-001 MULTAQ DRONEDARONE HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022425-001 8410167 2029-04-16 U-1387 2013-04-30 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 N022425-001 8602215 2031-06-30 U-1473 2014-01-08
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 2 · 42 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 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 210 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 2680178bc6a6…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-4142 Multaq Dronedarone sanofi-aventis U.S. LLC NDA Current 0024-4142 Multaq Dronedarone sanofi-aventis U.S. LLC NDA Current 0024-4142 Multaq Dronedarone sanofi-aventis U.S. LLC NDA Current 0024-4142 Multaq Dronedarone sanofi-aventis U.S. LLC NDA Current 0024-4142 Multaq Dronedarone sanofi-aventis U.S. LLC NDA Current 0024-4142 Multaq Dronedarone sanofi-aventis U.S. LLC NDA Current 0024-4142 Multaq Dronedarone sanofi-aventis U.S. LLC NDA Current 53360-4142 Multaq dronedarone Sanofi Winthrop Industries NDA Current 55154-8104 Multaq Dronedarone Cardinal Health 107, LLC NDA Current 55154-8104 Multaq Dronedarone Cardinal Health NDA Current 55154-8104 Multaq Dronedarone Cardinal Health NDA Current 55154-8104 Multaq Dronedarone Cardinal Health NDA Current