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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076420-001 | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076420-002 | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION / ORAL | 2006-06-21 | caaa826d4ba7… | ||
| 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… |
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 | Proficient Rx LP | 52273d60-3f27-4846-bf40-014ebcf09417 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Proficient Rx LP | b94ae2e4-e276-40c1-bc25-da980194fc99 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Asclemed USA, Inc. | 8ac9dc83-edb2-4ae5-8064-40f113fd3aab | 2020-10-14 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Dr.Reddy's Laboratories Limited | e1a0da17-d67c-e44f-bd42-33c4009e4cdd | 2018-12-10 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Amneal Pharmaceuticals of New York LLC | 380bddae-5b31-4965-96de-97711d859d11 | 2016-02-02 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |