Application 210500

Type: ANDA
Sponsor: HETERO LABS LTD III

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 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
A210500-001	DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-09-24
A210500-002	DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB		2020-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210500-001	AB
A210500-002	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 · 76 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	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210500-001	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210500-002	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE / ORAL	AB	2020-09-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A210500-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210500-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210500-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210500-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210500-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210500-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210500-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210500-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210500-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210500-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210500-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210500-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210500-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210500-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210500-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210500-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210500-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210500-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210500-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210500-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210500-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210500-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210500-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210500-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210500-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210500-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210500-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210500-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210500-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210500-002	AB	1	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A210500-001	PC	2021-02-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210500-002	PC	2021-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210500-001	PC	2021-02-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210500-002	PC	2021-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210500-001	PC	2021-02-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210500-002	PC	2021-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210500-001	PC	2021-02-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210500-002	PC	2021-02-14	`8869cabd3fbd…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIMETHYL FUMARATE	DIMETHYL FUMARATE	A-S Medication Solutions	c2b19329-5c1d-4879-85a9-36ffec3ff5cb	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210500 application number: ANDA210500 ndc (product): 50090-5288
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Quallent Pharmaceuticals Health LLC	39150ef0-ba48-4719-b7fd-9beb4d4ad3ce	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210500 application number: ANDA210500
DIMETHYL FUMARATE	DIMETHYL FUMARATE	Camber Pharmaceuticals, Inc.	b856ac70-71cd-477b-95b1-0a6132c260e8	2024-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210500 application number: ANDA210500 ndc (product): 31722-658 ndc (product): 31722-680 ndc (product): 31722-657

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-657	Dimethyl Fumarate	Dimethyl Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-658	Dimethyl Fumarate	Dimethyl Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-680	Dimethyl Fumarate	Dimethyl Fumarate	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-5288	Dimethyl Fumarate	Dimethyl Fumarate	A-S Medication Solutions	ANDA	Current
50090-5288	Dimethyl Fumarate	Dimethyl Fumarate	A-S Medication Solutions	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57987	ORIG	2019-03-13