Application 210285

Type: ANDA
Sponsor: SAWAI USA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A210285-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL			2021-12-21
A210285-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL			2021-12-21

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 2 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2021-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2021-12-21	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210285-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210285-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL		2021-12-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210285-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210285-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210285-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210285-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210285-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210285-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210285-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210285-002	AB	1	`bb7c543d1eb4…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dimethyl Fumarate	DIMETHYL FUMARATE	Golden State Medical Supply, Inc.	5361d5c6-c3eb-88e6-e063-6294a90ac08c	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Dimethyl Fumarate generic name: DIMETHYL FUMARATE
dimethyl fumarate	DIMETHYL FUMARATE	Golden State Medical Supply, Inc.	b8e5184d-5d1d-0a89-e053-2995a90a2d6d	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: dimethyl fumarate generic name: DIMETHYL FUMARATE
dimethyl fumarate	DIMETHYL FUMARATE	Upsher-Smith Laboratories, LLC	48f56f42-2247-41a9-a1e9-07c3af50e549	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: dimethyl fumarate generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	A-S Medication Solutions	c2b19329-5c1d-4879-85a9-36ffec3ff5cb	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: DIMETHYL FUMARATE generic name: DIMETHYL FUMARATE
Dimethyl Fumarate	DIMETHYL FUMARATE	SOLA Pharmaceuticals, LLC	b4a200c1-f25a-4aa8-8770-06182fdeda9d	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Dimethyl Fumarate generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Quallent Pharmaceuticals Health LLC	39150ef0-ba48-4719-b7fd-9beb4d4ad3ce	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: DIMETHYL FUMARATE generic name: DIMETHYL FUMARATE
Dimethyl Fumarate	DIMETHYL FUMARATE	Dr. Reddy's Laboratories Inc.	b00dcf89-59d3-9ab2-fd9b-16b9ec2d677b	2025-10-10	Warnings, Adverse reactions	Name fallback brand name: Dimethyl Fumarate generic name: DIMETHYL FUMARATE
Dimethyl fumarate	DIMETHYL FUMARATE	Ascend Laboratories, LLC	e12d8fee-bd18-4f84-8333-c890f1d132b7	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Dimethyl fumarate generic name: DIMETHYL FUMARATE
Dimethyl Fumarate	DIMETHYL FUMARATE	Macleods Pharmaceuticals Limited	f8ada3e3-55c0-43e3-95b9-c6d11ffc42dd	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Dimethyl Fumarate generic name: DIMETHYL FUMARATE
Dimethyl fumarate	DIMETHYL FUMARATE	CivicaScript LLC	f3002b6a-841e-4247-9155-3acfb30cabcd	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: Dimethyl fumarate generic name: DIMETHYL FUMARATE
TECFIDERA	DIMETHYL FUMARATE	Biogen Inc.	665d7e74-036c-5f68-5b67-ab84b9b49151	2025-06-04	Warnings, Adverse reactions	Name fallback generic name: DIMETHYL FUMARATE
Dimethyl Fumarate	DIMETHYL FUMARATE	Amneal Pharmaceuticals NY LLC	4c7626c6-2b1b-4865-818c-0c79c18c049d	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Dimethyl Fumarate generic name: DIMETHYL FUMARATE
dimethyl fumarate	DIMETHYL FUMARATE	Zydus Pharmaceuticals USA Inc.	e7ef9b9e-d97a-4a56-b792-a1a255613156	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: dimethyl fumarate generic name: DIMETHYL FUMARATE
dimethyl fumarate	DIMETHYL FUMARATE	Zydus Lifesciences Limited	7203a262-de0f-42dd-b4fb-8856758b82e9	2025-04-01		Name fallback brand name: dimethyl fumarate generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Solco Healthcare US, LLC	a3677dce-a44b-481f-8a76-9ff3a4d42105	2024-06-27	Warnings, Adverse reactions	Name fallback brand name: DIMETHYL FUMARATE generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Camber Pharmaceuticals, Inc.	b856ac70-71cd-477b-95b1-0a6132c260e8	2024-05-10	Warnings, Adverse reactions	Name fallback brand name: DIMETHYL FUMARATE generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATE	DIMETHYL-FUMARATE	Glenmark Pharmaceuticals Inc., USA	c3f65da9-f5f4-4161-aded-c23b16fd49ed	2024-04-23	Warnings, Adverse reactions	Name fallback brand name: DIMETHYL FUMARATE
Dimethyl Fumarate	DIMETHYL FUMARATE	Aurobindo Pharma Limited	08f3a987-6571-42b3-854b-186d782b4494	2024-04-11	Warnings, Adverse reactions	Name fallback brand name: Dimethyl Fumarate generic name: DIMETHYL FUMARATE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Cipla USA Inc.	6c42107a-2a42-4263-97b6-ae0d7675c92a	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: DIMETHYL FUMARATE generic name: DIMETHYL FUMARATE
Dimethyl Fumarate	DIMETHYL FUMARATE	MSN LABORATORIES PRIVATE LIMITED	074d2820-6cb4-437a-8f6f-a21cb0a8ee02	2021-07-13	Warnings, Adverse reactions	Name fallback brand name: Dimethyl Fumarate generic name: DIMETHYL FUMARATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58379	ORIG	2019-04-24