Application 204063

Type: NDA
Sponsor: BIOGEN IDEC INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TECFIDERA	DIMETHYL FUMARATE	CAPSULE, DELAYED RELEASE;ORAL	120MG	Yes	No
002	TECFIDERA	DIMETHYL FUMARATE	CAPSULE, DELAYED RELEASE;ORAL	240MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204063-001	TECFIDERA	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27
N204063-002	TECFIDERA	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N204063-001	AB
N204063-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N204063-001	8399514	2028-02-07	U-1384	2013-04-24
N204063-001	10391160	2035-03-13	U-3148	2021-04-28
N204063-001	10555993	2035-03-13	U-3148	2021-04-28
N204063-001	10994003	2035-03-13	U-3148	2021-05-28
N204063-001	10959972	2035-11-16	U-1384	2021-04-28
N204063-001	11007166	2035-11-16	U-1384	2021-05-28
N204063-001	11007167	2035-11-16	U-1384	2021-05-28
N204063-001	11129806	2035-11-16	U-1384	2021-10-27
N204063-001	11246850	2035-11-16	U-1384	2022-03-11
N204063-002	8399514	2028-02-07	U-1384	2013-04-24
N204063-002	10391160	2035-03-13	U-3148	2021-04-28
N204063-002	10555993	2035-03-13	U-3148	2021-04-28
N204063-002	10994003	2035-03-13	U-3148	2021-05-28
N204063-002	10959972	2035-11-16	U-1384	2021-04-28
N204063-002	11007166	2035-11-16	U-1384	2021-05-28
N204063-002	11007167	2035-11-16	U-1384	2021-05-28
N204063-002	11129806	2035-11-16	U-1384	2021-10-27
N204063-002	11246850	2035-11-16	U-1384	2022-03-11

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2013-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204063-001	TECFIDERA	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2013-03-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204063-002	TECFIDERA	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-03-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204063-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204063-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204063-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204063-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204063-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204063-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204063-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204063-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204063-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204063-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204063-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204063-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204063-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204063-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204063-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204063-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204063-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204063-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204063-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204063-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204063-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204063-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204063-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 640 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204063-001	8399514	2028-02-07	U-1384	2013-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10391160	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10555993	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10994003	2035-03-13	U-3148	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	10959972	2035-11-16	U-1384	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11007166	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11007167	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11129806	2035-11-16	U-1384	2021-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-001	11246850	2035-11-16	U-1384	2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	8399514	2028-02-07	U-1384	2013-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10391160	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10555993	2035-03-13	U-3148	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10994003	2035-03-13	U-3148	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	10959972	2035-11-16	U-1384	2021-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11007166	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11007167	2035-11-16	U-1384	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11129806	2035-11-16	U-1384	2021-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204063-002	11246850	2035-11-16	U-1384	2022-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	8399514	2028-02-07	U-1384	2013-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10391160	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10555993	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10994003	2035-03-13	U-3148	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	10959972	2035-11-16	U-1384	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11007166	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11007167	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11129806	2035-11-16	U-1384	2021-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-001	11246850	2035-11-16	U-1384	2022-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	8399514	2028-02-07	U-1384	2013-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10391160	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10555993	2035-03-13	U-3148	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10994003	2035-03-13	U-3148	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	10959972	2035-11-16	U-1384	2021-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11007166	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11007167	2035-11-16	U-1384	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11129806	2035-11-16	U-1384	2021-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204063-002	11246850	2035-11-16	U-1384	2022-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204063-001	8399514	2028-02-07	U-1384	2013-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-001	10391160	2035-03-13	U-3148	2021-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-001	10555993	2035-03-13	U-3148	2021-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204063-001	10994003	2035-03-13	U-3148	2021-05-28	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-001	M-260	2023-02-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204063-002	M-260	2023-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204063-001	M-260	2023-02-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204063-002	M-260	2023-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204063-001	M-260	2023-02-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204063-002	M-260	2023-02-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204063-001	M-260	2023-02-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204063-002	M-260	2023-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204063-001	M-260	2023-02-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204063-002	M-260	2023-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-001	M-260	2023-02-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204063-002	M-260	2023-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204063-001	M-260	2023-02-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204063-002	M-260	2023-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204063-001	M-260	2023-02-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204063-002	M-260	2023-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204063-001	M-260	2023-02-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204063-002	M-260	2023-02-05	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N204063-001	M-260	2023-02-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N204063-002	M-260	2023-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204063-001	M-260	2023-02-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204063-002	M-260	2023-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204063-001	M-260	2023-02-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204063-002	M-260	2023-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204063-001	M-260	2023-02-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204063-002	M-260	2023-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204063-001	M-260	2023-02-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204063-002	M-260	2023-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204063-001	M-260	2023-02-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N204063-002	M-260	2023-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204063-001	M-260	2023-02-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N204063-002	M-260	2023-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204063-001	M-260	2023-02-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204063-002	M-260	2023-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204063-001	M-260	2023-02-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204063-002	M-260	2023-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204063-001	M-260	2023-02-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N204063-002	M-260	2023-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204063-001	M-260	2023-02-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204063-002	M-260	2023-02-05	`cb3db0bc1861…`

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
TECFIDERA	DIMETHYL FUMARATE	Biogen Inc.	665d7e74-036c-5f68-5b67-ab84b9b49151	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204063 application number: NDA204063 ndc (product): 64406-006 ndc (product): 64406-005 ndc (product): 64406-007

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-9218	dimethyl fumarate	dimethyl fumarate	TEVA PHARMACEUTICALS USA, INC.	NDA	Current
0093-9218	dimethyl fumarate	dimethyl fumarate	TEVA PHARMACEUTICALS USA, INC.	NDA	Current
0093-9218	dimethyl fumarate	dimethyl fumarate	TEVA PHARMACEUTICALS USA, INC.	NDA	Current
0093-9219	dimethyl fumarate	dimethyl fumarate	TEVA PHARMACEUTICALS USA, INC.	NDA	Current
0093-9219	dimethyl fumarate	dimethyl fumarate	TEVA PHARMACEUTICALS USA, INC.	NDA	Current
0093-9219	dimethyl fumarate	dimethyl fumarate	TEVA PHARMACEUTICALS USA, INC.	NDA	Current
64406-005	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-005	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-006	TECFIDERA	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current
64406-007	Tecfidera	dimethyl fumarate	Biogen Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77815	SUPPL	2024-03-13
77810	SUPPL	2024-03-13
76839	SUPPL	2023-12-14
76795	SUPPL	2023-12-14
73493	SUPPL	2023-02-14
73465	SUPPL	2023-02-13
72219	SUPPL	2022-10-03
72218	SUPPL	2022-10-03
72195	SUPPL	2022-09-30
72194	SUPPL	2022-09-30
70156	SUPPL	2022-02-14
66047	SUPPL	2021-02-01
66036	SUPPL	2021-02-01
61846	SUPPL	2020-02-07
61805	SUPPL	2020-02-06
61258	SUPPL	2019-12-12
61245	SUPPL	2019-12-12
59316	SUPPL	2019-07-11
59310	SUPPL	2019-07-11
50835	SUPPL	2017-12-22
50784	SUPPL	2017-12-20
46955	SUPPL	2017-01-24
46950	SUPPL	2017-01-24
22942	SUPPL	2016-07-28
19522	SUPPL	2016-03-03
32501	SUPPL	2016-03-02
44432	ORIG	2014-12-23
40351	SUPPL	2014-12-10
19521	SUPPL	2014-12-10
19520	SUPPL	2014-12-10
32500	SUPPL	2014-12-04
32499	SUPPL	2014-12-04
32498	SUPPL	2014-12-04
10291	SUPPL	2014-11-18
24457	ORIG	2013-04-25
22941	ORIG	2013-04-25
40350	ORIG	2013-03-29
10290	ORIG	2013-03-29