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 43.

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	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 · 43 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
2026-09-14 22:38:34	2026-08	N022425-001	MULTAQ	EQ 400MG BASE	TABLET / ORAL		RLD, RS	2009-07-01	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022425-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022425-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022425-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022425-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022425-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022425-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022425-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022425-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022425-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022425-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022425-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022425-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022425-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022425-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022425-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022425-001	AB	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022425-001	8410167	2029-04-16	U-1387	2013-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022425-001	8410167	2029-04-16	U-1388	2013-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022425-001	9107900	2029-04-16	U-1728	2015-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022425-001	9107900	2029-04-16	U-1726	2015-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022425-001	8602215	2031-06-30	U-1473	2014-01-08	`84e616aacf4f…`
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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Multaq	DRONEDARONE	Cardinal Health 107, LLC	3bd4006a-8bad-4909-ac6d-b6d84390155c	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022425 application number: NDA022425 ndc (product): 55154-8104
Multaq	DRONEDARONE	Sanofi-Aventis U.S. LLC	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022425 application number: NDA022425 ndc (product): 0024-4142

Reported adverse events (FAERS/openFDA)#

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

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75923	SUPPL	2023-10-25
75922	SUPPL	2023-10-25
75921	SUPPL	2023-10-25
75903	SUPPL	2023-10-24
75902	SUPPL	2023-10-24
65543	SUPPL	2020-12-09
65269	SUPPL	2020-11-18
65251	SUPPL	2020-11-17
56376	SUPPL	2018-11-08
7378	SUPPL	2016-02-16
17576	SUPPL	2014-06-23
7377	SUPPL	2014-04-03
7375	SUPPL	2014-03-20
7376	SUPPL	2014-02-04
38699	SUPPL	2014-01-31
17575	SUPPL	2013-04-01
7374	SUPPL	2013-03-29
38698	SUPPL	2012-09-11
38697	SUPPL	2012-09-11
17574	SUPPL	2012-09-11
29719	SUPPL	2012-09-10
29718	SUPPL	2012-09-10
7373	SUPPL	2012-09-10
17573	SUPPL	2012-06-18
29717	SUPPL	2012-06-15
38694	SUPPL	2012-01-31
29712	SUPPL	2012-01-30
29716	SUPPL	2011-12-21
17572	SUPPL	2011-12-19
38696	SUPPL	2011-09-07
7372	SUPPL	2011-09-06
7370	SUPPL	2011-08-11
17571	SUPPL	2011-06-29
7371	SUPPL	2011-06-27
29715	SUPPL	2011-03-14
38695	SUPPL	2011-03-11
38693	SUPPL	2011-02-24
29714	SUPPL	2011-02-15
29711	SUPPL	2011-02-15
29713	SUPPL	2011-02-04
17570	SUPPL	2011-01-31
23398	ORIG	2009-11-19
44752	ORIG	2009-08-20
22017	ORIG	2009-08-20
29710	ORIG	2009-07-30
38692	ORIG	2009-07-06