Application 210382

Type: ANDA
Sponsor: TWI PHARMS INC

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, EXTENDED RELEASE;ORAL	240MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210382-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-10-14
A210382-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210382-001	AB
A210382-002	AB

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 · 74 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
2026-08-18 06:07:40	2026-07	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210382-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210382-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-10-14	`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
2026-08-18 06:07:40	2026-07	A210382-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210382-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210382-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210382-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210382-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210382-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210382-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210382-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210382-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210382-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210382-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210382-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210382-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210382-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210382-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210382-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210382-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210382-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210382-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210382-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210382-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210382-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210382-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210382-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210382-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210382-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210382-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210382-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210382-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210382-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210382-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210382-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210382-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210382-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210382-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210382-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210382-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210382-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210382-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210382-002	AB	1	`782e0a99824c…`

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
dimethyl fumarate	DIMETHYL FUMARATE	Golden State Medical Supply, Inc.	b8e5184d-5d1d-0a89-e053-2995a90a2d6d	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210382 application number: ANDA210382 ndc (product): 51407-441 ndc (product): 51407-442
dimethyl fumarate	DIMETHYL FUMARATE	Upsher-Smith Laboratories, LLC	48f56f42-2247-41a9-a1e9-07c3af50e549	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210382 application number: ANDA210382 ndc (product): 24979-127 ndc (product): 24979-128

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24979-127	dimethyl fumarate	dimethyl fumarate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-127	dimethyl fumarate	dimethyl fumarate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-127	dimethyl fumarate	dimethyl fumarate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-128	dimethyl fumarate	dimethyl fumarate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-128	dimethyl fumarate	dimethyl fumarate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-128	dimethyl fumarate	dimethyl fumarate	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-129	dimethyl fumarate	dimethyl fumarate	TWi Pharmaceuticals, Inc.	ANDA	Current
51407-441	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-441	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-441	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-441	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-441	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-442	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-442	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-442	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-442	dimethyl fumarate	dimethyl fumarate	Golden State Medical Supply, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57786	ORIG	2019-02-22