Application 206646
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DALFAMPRIDINE | DALFAMPRIDINE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206646-001 | DALFAMPRIDINE | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-10-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A206646-001 | DALFAMPRIDINE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2018-10-24 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-08 23:34 UTC | 2022-04 | A206646-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206646-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206646-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206646-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206646-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206646-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206646-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206646-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206646-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206646-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206646-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206646-001 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dalfampridine | DALFAMPRIDINE | Ascend Laboratories, LLC | e10b2d92-2824-4395-8883-6fd52c784aa4 | 2026-07-14 | Warnings, Adverse reactions | Dalfampridine DALFAMPRIDINE |
| AMPYRA | DALFAMPRIDINE | Merz Pharmaceuticals, LLC | 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783 | 2026-01-16 | Warnings, Adverse reactions | DALFAMPRIDINE |
| Dalfampridine | DALFAMPRIDINE | Accord Healthcare Inc. | 354a97e8-35c8-418b-91b2-9e8e066cec65 | 2025-10-09 | Warnings, Adverse reactions | Dalfampridine DALFAMPRIDINE |
| DALFAMPRIDINE | DALFAMPRIDINE | Micro Labs Limited | 302c8270-4711-4ca4-bee8-be0738fbe094 | 2025-07-28 | Warnings, Adverse reactions | DALFAMPRIDINE DALFAMPRIDINE |
| Dalfampridine | DALFAMPRIDINE | CivicaScript LLC | c40dcc84-b839-44aa-94f2-886fb1c3d75c | 2025-07-16 | Warnings, Adverse reactions | Dalfampridine DALFAMPRIDINE |
| AMPYRA | DALFAMPRIDINE | Merz Pharmaceuticals, LLC | 974fb2af-7012-4989-b330-e44a31c9c3e5 | 2025-05-05 | Warnings, Adverse reactions | DALFAMPRIDINE |
| DALFAMPRIDINE | DALFAMPRIDINE | Bryant Ranch Prepack | 688eb479-debc-4cfc-a74d-14828c347049 | 2025-02-12 | Warnings, Adverse reactions | DALFAMPRIDINE DALFAMPRIDINE |
| DALFAMPRIDINE | DALFAMPRIDINE | Aurobindo Pharma Limited | 43996322-7d83-4420-9e61-4ed37f710fee | 2024-02-15 | Warnings, Adverse reactions | DALFAMPRIDINE DALFAMPRIDINE |
| Dalfampridine | DALFAMPRIDINE | Golden State Medical Supply, Inc. | 1134ac0f-59c1-a20b-e063-6294a90affcc | 2024-02-12 | Warnings, Adverse reactions | Dalfampridine DALFAMPRIDINE |
| Dalfampridine | DALFAMPRIDINE | Sun Pharmaceutical Industries, Inc. | d61e15fa-0334-49a0-ab41-c9a36b726b57 | 2023-10-16 | Warnings, Adverse reactions | Dalfampridine DALFAMPRIDINE |
| Dalfampridine | DALFAMPRIDINE | Actavis Pharma, Inc. | ed826777-b8c4-4d35-aa64-a4c28452baa8 | 2021-12-02 | Warnings, Adverse reactions | Dalfampridine DALFAMPRIDINE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0479 | Dalfampridine | Dalfampridine | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0479 | Dalfampridine | Dalfampridine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0479 | Dalfampridine | Dalfampridine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |