Application 204063

Type: NDA
Sponsor: BIOGEN IDEC INC

Related Records

Company: BIOGEN IDEC INC

Application Products

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

NDC Listings For This Application

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
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