Application 211855

Type: NDA
Sponsor: BIOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VUMERITY	DIROXIMEL FUMARATE	CAPSULE, DELAYED RELEASE;ORAL	231MG	Yes	Yes

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

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
N211855-001	VUMERITY	DIROXIMEL FUMARATE	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N211855-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22
N211855-001	9090558	2033-09-20	U-1384		2019-11-22
N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22

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
2026-02-19 14:30 UTC	2026-02	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-10-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211855-001	VUMERITY	231MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-10-29	`a50c72e98297…`

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	N211855-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211855-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211855-001	8669281	2033-10-29		Drug substance, Drug product	2019-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211855-001	8669281	2033-09-20		Drug substance, Drug product	2019-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211855-001	9090558	2033-09-20	U-1384		2019-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211855-001	10080733	2033-09-20	U-1384	Drug substance, Drug product	2019-11-22	`8072bd15b7f6…`

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
Vumerity	DIROXIMEL FUMARATE	Biogen Inc.	2d74414f-6b83-4ea2-9a95-3cecabbce774	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211855 application number: NDA211855 ndc (product): 64406-020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64406-020	Vumerity	diroximel fumarate	Biogen Inc.	NDA	Current
64406-020	Vumerity	diroximel fumarate	Biogen Inc.	NDA	Current
64406-020	Vumerity	diroximel fumarate	Biogen Inc.	NDA	Current
64406-020	Vumerity	diroximel fumarate	Biogen Inc.	NDA	Current
64406-020	Vumerity	diroximel fumarate	Biogen Inc.	NDA	Current
64406-020	Vumerity	diroximel fumarate	Biogen Inc.	NDA	Current
64406-020	Vumerity	diroximel fumarate	Biogen Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79617	SUPPL	2024-09-16
79584	SUPPL	2024-09-16
77942	SUPPL	2024-03-25
77933	SUPPL	2024-03-25
76832	SUPPL	2023-12-14
76804	SUPPL	2023-12-14
73494	SUPPL	2023-02-14
73469	SUPPL	2023-02-13
73253	SUPPL	2023-01-19
73189	SUPPL	2023-01-17
72220	SUPPL	2022-10-03
72217	SUPPL	2022-10-03
72190	SUPPL	2022-09-30
70150	SUPPL	2022-02-14
70148	SUPPL	2022-02-11
66051	SUPPL	2021-02-01
66037	SUPPL	2021-02-01
64483	SUPPL	2020-09-02
64403	SUPPL	2020-08-25
62622	ORIG	2020-04-21
60773	ORIG	2019-11-01
60731	ORIG	2019-10-30