Application 076420
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE;ORAL | 5MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET, CHEWABLE;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076420-001 | LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | ||
| A076420-002 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 |
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 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, CHEWABLE / ORAL | 2006-06-21 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A076420-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076420-002 | 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 |
|---|---|---|---|---|---|---|
| Lamotrigine | LAMOTRIGINE | A-S Medication Solutions | 6139a858-700c-4eb9-9f84-99d280bde326 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Dr. Reddys Laboratories Inc. | 54ea1ec3-876b-4d3a-a92b-1a6d70951de0 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| LAMOTRIGINE | LAMOTRIGINE | Golden State Medical Supply, Inc. | 57f04b9b-06cd-8044-e063-6394a90ae733 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | American Health Packaging | 35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| LAMOTRIGINE | LAMOTRIGINE | REMEDYREPACK INC. | 50d46278-636a-470e-afcc-d3c8bd844e46 | 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 | 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-0132 | Lamotrigine | Lamotrigine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0688 | Lamotrigine | Lamotrigine | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42291-353 | Lamotrigine | Lamotrigine | AvKARE, Inc. | ANDA | Current |
| 42291-354 | Lamotrigine | Lamotrigine | AvKARE, Inc. | ANDA | Current |
| 68151-4249 | Lamotrigine | Lamotrigine | Carilion Materials Management | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31119 | ORIG | 2008-06-28 |