Application 216806
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LACOSAMIDE | LACOSAMIDE | SOLUTION;INTRAVENOUS | 200MG/20ML (10MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216806-001 | LACOSAMIDE | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216806-001 | AP |
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 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | 8072bd15b7f6… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216806-001 | LACOSAMIDE | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS | AP | 2024-04-05 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A216806-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216806-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216806-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216806-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216806-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216806-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216806-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216806-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216806-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216806-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216806-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216806-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216806-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216806-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216806-001 | AP | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216806-001 | AP | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Lacosamide | LACOSAMIDE | Novadoz Pharmaceuticals LLC | b9a0ca8c-593c-48e8-b2a7-d30d5f6e6a9b | 2026-08-12 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Westminster Pharmaceuticals, LLC | ecb8b33e-7cbd-4f5e-9fe9-e72dff9bcb86 | 2026-08-11 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Glenmark Pharmaceuticals Limited | 458e80da-8fc1-4715-9b4b-bc4f388f933f | 2026-08-11 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | REMEDYREPACK INC. | edd20b60-6265-4c4e-a95a-aaf8103cd852 | 2026-07-21 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Fosun Pharma USA | ec1c5ddb-1143-7e6a-e053-2995a90a8382 | 2026-07-21 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Gland Pharma Limited | 779d2381-f590-45f9-a191-f44af821f4c8 | 2026-07-14 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | REMEDYREPACK INC. | d823fbfa-8ff5-4ef8-84ce-fbe916d4e430 | 2026-07-07 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Aurobindo Pharma Limited | 6140b3f1-ff60-427c-91d7-15af99fd78f1 | 2026-06-29 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Aurobindo Pharma Limited | 614490ce-a62c-4222-8e4b-ce802cf63028 | 2026-06-22 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| LACOSAMIDE | LACOSAMIDE | Camber Pharmaceuticals, Inc. | c5b91128-f838-4e98-9684-5f477fc7af06 | 2026-06-22 | Warnings, Adverse reactions | LACOSAMIDE LACOSAMIDE |
| LACOSAMIDE | LACOSAMIDE | Zydus Pharmaceuticals USA Inc. | 16a9afd2-35a6-44a9-b1d9-ca195c8640d7 | 2026-06-11 | Warnings, Adverse reactions | LACOSAMIDE LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Major Pharmaceuticals | c83d2156-4dde-4316-98f1-b3dc751f3eac | 2026-06-09 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | NorthStar Rx LLC | 48fcaa27-baaa-446e-a282-0c3e232cd151 | 2026-05-28 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Dr. Reddy's Laboratories Inc. | cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b4 | 2026-05-21 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| Vimpat | LACOSAMIDE | UCB, Inc. | 9e79b42c-38a3-4b2c-a196-a5a1948250e2 | 2026-05-12 | Warnings, Adverse reactions | LACOSAMIDE |
| LACOSAMIDE | LACOSAMIDE | Zydus Pharmaceuticals USA Inc. | 07356cf2-224b-40d2-b827-e10a6b42c232 | 2026-05-07 | Warnings, Adverse reactions | LACOSAMIDE LACOSAMIDE |
| Lacosamide | LACOSAMIDE | Bryant Ranch Prepack | 024bca92-cac5-4832-a1ff-c1b3d5994ba0 | 2026-05-06 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |
| LACOSAMIDE | LACOSAMIDE | Camber Pharmaceuticals, Inc. | e24d3c45-a559-4fca-a7be-74ce37a7066e | 2026-04-14 | Warnings, Adverse reactions | LACOSAMIDE LACOSAMIDE |
| LACOSAMIDE | LACOSAMIDE | Clinical Solutions Wholesale, LLC | 264c3718-67ea-4483-b036-2514c853635a | 2026-03-24 | Warnings, Adverse reactions | LACOSAMIDE LACOSAMIDE |
| Lacosamide | LACOSAMIDE | American Health Packaging | 19060029-c158-4a37-9261-cfe3b2b5b1e3 | 2026-03-06 | Warnings, Adverse reactions | Lacosamide LACOSAMIDE |