Application 078645
- Type
- ANDA
- Sponsor
- SANDOZ
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 |
|---|---|---|---|---|---|---|---|
| A078645-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | ||
| A078645-002 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | ||
| A078645-003 | LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | ||
| A078645-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078645-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078645-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078645-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078645-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2009-01-27 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|
| 0781-4040 | Lamotrigine | Lamotrigine | Sandoz Inc | ANDA | Current |
| 0781-5122 | Lamotrigine | Lamotrigine | Sandoz Inc | ANDA | Current |
| 0781-5123 | Lamotrigine | Lamotrigine | Sandoz Inc | ANDA | Current |
| 0781-5124 | Lamotrigine | Lamotrigine | Sandoz Inc | ANDA | Current |
| 0781-5125 | Lamotrigine | Lamotrigine | Sandoz Inc | ANDA | Current |