Application 210285
- Type
- ANDA
- Sponsor
- SAWAI USA
Application Products#
| 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 |
Orange Book products#
| 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.
| 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 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | 2021-12-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2021-12-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2021-12-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2021-12-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2021-12-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210285-001 | DIMETHYL FUMARATE | 120MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2021-12-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210285-002 | DIMETHYL FUMARATE | 240MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2021-12-21 | 4b0b4de00fa7… | |
| 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… |
Observed Orange Book normalized TE history#
| 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#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| 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 | Dimethyl Fumarate DIMETHYL FUMARATE |
| dimethyl fumarate | DIMETHYL FUMARATE | Golden State Medical Supply, Inc. | b8e5184d-5d1d-0a89-e053-2995a90a2d6d | 2026-04-15 | Warnings, Adverse reactions | dimethyl fumarate DIMETHYL FUMARATE |
| dimethyl fumarate | DIMETHYL FUMARATE | Upsher-Smith Laboratories, LLC | 48f56f42-2247-41a9-a1e9-07c3af50e549 | 2026-01-19 | Warnings, Adverse reactions | dimethyl fumarate DIMETHYL FUMARATE |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | A-S Medication Solutions | c2b19329-5c1d-4879-85a9-36ffec3ff5cb | 2026-01-13 | Warnings, Adverse reactions | DIMETHYL FUMARATE DIMETHYL FUMARATE |
| Dimethyl Fumarate | DIMETHYL FUMARATE | SOLA Pharmaceuticals, LLC | b4a200c1-f25a-4aa8-8770-06182fdeda9d | 2025-12-08 | Warnings, Adverse reactions | Dimethyl Fumarate DIMETHYL FUMARATE |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | Quallent Pharmaceuticals Health LLC | 39150ef0-ba48-4719-b7fd-9beb4d4ad3ce | 2025-10-30 | Warnings, Adverse reactions | DIMETHYL FUMARATE DIMETHYL FUMARATE |
| Dimethyl Fumarate | DIMETHYL FUMARATE | Dr. Reddy's Laboratories Inc. | b00dcf89-59d3-9ab2-fd9b-16b9ec2d677b | 2025-10-10 | Warnings, Adverse reactions | Dimethyl Fumarate DIMETHYL FUMARATE |
| Dimethyl fumarate | DIMETHYL FUMARATE | Ascend Laboratories, LLC | e12d8fee-bd18-4f84-8333-c890f1d132b7 | 2025-09-26 | Warnings, Adverse reactions | Dimethyl fumarate DIMETHYL FUMARATE |
| Dimethyl Fumarate | DIMETHYL FUMARATE | Macleods Pharmaceuticals Limited | f8ada3e3-55c0-43e3-95b9-c6d11ffc42dd | 2025-07-29 | Warnings, Adverse reactions | Dimethyl Fumarate DIMETHYL FUMARATE |
| Dimethyl fumarate | DIMETHYL FUMARATE | CivicaScript LLC | f3002b6a-841e-4247-9155-3acfb30cabcd | 2025-06-10 | Warnings, Adverse reactions | Dimethyl fumarate DIMETHYL FUMARATE |
| TECFIDERA | DIMETHYL FUMARATE | Biogen Inc. | 665d7e74-036c-5f68-5b67-ab84b9b49151 | 2025-06-04 | Warnings, Adverse reactions | DIMETHYL FUMARATE |
| Dimethyl Fumarate | DIMETHYL FUMARATE | Amneal Pharmaceuticals NY LLC | 4c7626c6-2b1b-4865-818c-0c79c18c049d | 2025-05-30 | Warnings, Adverse reactions | Dimethyl Fumarate DIMETHYL FUMARATE |
| dimethyl fumarate | DIMETHYL FUMARATE | Zydus Pharmaceuticals USA Inc. | e7ef9b9e-d97a-4a56-b792-a1a255613156 | 2025-04-01 | Warnings, Adverse reactions | dimethyl fumarate DIMETHYL FUMARATE |
| dimethyl fumarate | DIMETHYL FUMARATE | Zydus Lifesciences Limited | 7203a262-de0f-42dd-b4fb-8856758b82e9 | 2025-04-01 | dimethyl fumarate DIMETHYL FUMARATE | |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | Solco Healthcare US, LLC | a3677dce-a44b-481f-8a76-9ff3a4d42105 | 2024-06-27 | Warnings, Adverse reactions | DIMETHYL FUMARATE DIMETHYL FUMARATE |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | Camber Pharmaceuticals, Inc. | b856ac70-71cd-477b-95b1-0a6132c260e8 | 2024-05-10 | Warnings, Adverse reactions | DIMETHYL FUMARATE DIMETHYL FUMARATE |
| DIMETHYL FUMARATE | DIMETHYL-FUMARATE | Glenmark Pharmaceuticals Inc., USA | c3f65da9-f5f4-4161-aded-c23b16fd49ed | 2024-04-23 | Warnings, Adverse reactions | DIMETHYL FUMARATE |
| Dimethyl Fumarate | DIMETHYL FUMARATE | Aurobindo Pharma Limited | 08f3a987-6571-42b3-854b-186d782b4494 | 2024-04-11 | Warnings, Adverse reactions | Dimethyl Fumarate DIMETHYL FUMARATE |
| DIMETHYL FUMARATE | DIMETHYL FUMARATE | Cipla USA Inc. | 6c42107a-2a42-4263-97b6-ae0d7675c92a | 2024-03-22 | Warnings, Adverse reactions | DIMETHYL FUMARATE DIMETHYL FUMARATE |
| Dimethyl Fumarate | DIMETHYL FUMARATE | MSN LABORATORIES PRIVATE LIMITED | 074d2820-6cb4-437a-8f6f-a21cb0a8ee02 | 2021-07-13 | Warnings, Adverse reactions | Dimethyl Fumarate DIMETHYL FUMARATE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58379 | ORIG | 2019-04-24 |