Application 078982
- Type
- ANDA
- Sponsor
- CELLTRION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 25MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 100MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 150MG | No | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078982-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | ||
| A078982-002 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | ||
| A078982-003 | LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | ||
| A078982-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 |
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 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078982-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078982-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078982-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078982-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Lamotrigine | LAMOTRIGINE | American Health Packaging | 35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Inc. | 60958229-5b5f-49e2-97f4-a8722138f7ce | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| LAMOTRIGINE | LAMOTRIGINE | REMEDYREPACK INC. | 1d7c2d52-a78e-4508-8853-ba306cdeeaba | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 15d801a0-f0a5-40c1-bc88-d5ba9a02c696 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | d1691a60-ff0a-4755-b445-1d78309d5af0 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 346f8af3-b850-48e4-bd6e-82ecafca86d2 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | f5761818-4eaf-4335-a77a-9cd703278ded | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | fa679e97-3b3d-4bf2-8de7-da3a89e38b37 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| LAMOTRIGINE | LAMOTRIGINE | Torrent Pharmaceuticals Limited | 22225cc4-028e-43ad-8e1f-dcebdc244ecb | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 6ef17301-6c0b-4941-a84d-12243875d2e2 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 1b5646a9-4724-44b8-8cd0-9c14f5e87f86 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| LAMOTRIGINE | LAMOTRIGINE | Torrent Pharmaceuticals Limited | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| LAMOTRIGINE | LAMOTRIGINE | REMEDYREPACK INC. | 50d46278-636a-470e-afcc-d3c8bd844e46 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 55f41c7e-03a6-b84c-e063-6294a90a7d82 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 3ed4590d-71e3-4208-b6c0-98330acc7b85 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | de7f61ca-e3c0-4a09-b664-0df2de6a0c30 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 545fcc0e-1e2b-bdcb-e063-6294a90a4ac7 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | b1601109-5c17-4482-9257-1e0be7546e8f | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| SUBVENITE | LAMOTRIGINE | OWP Pharmaceuticals, Inc. | 022b0913-f683-4af8-a862-f81b315909b2 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Sun Pharmaceutical Industries, Inc. | b829f9b2-f0ac-408a-a6f4-18b72150227d | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |