Application 077783
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|---|---|---|---|---|---|---|
| A077783-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | ||
| A077783-002 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | ||
| A077783-003 | LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | ||
| A077783-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 |
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 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077783-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | 2010-11-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077783-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | 2010-11-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077783-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | 2010-11-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077783-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | 2010-11-01 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077783-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077783-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077783-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077783-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A077783-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077783-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077783-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077783-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077783-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077783-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077783-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077783-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077783-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077783-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077783-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077783-004 | 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 | Northwind Health Company, LLC | f7587283-781b-e111-e053-6394a90ad4cc | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Northstar Rx LLC. | aabc64fe-1f17-4140-81f2-7d4506db6c8b | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| lamotrigine | LAMOTRIGINE EXTENDED-RELEASE | Yiling Pharmaceutical, Inc. | f7de11a5-5357-4753-b1ac-b15123b50028 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | lamotrigine |
| Lamotrigine | LAMOTRIGINE | A-S Medication Solutions | 84277e2c-370c-4510-92bc-ef33a4a0f508 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Amneal Pharmaceuticals of New York LLC | 9e5c2d76-47a6-4a57-b23c-2398b307380c | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Ajanta Pharma USA Inc. | 9dfb5f87-0150-4c26-a89f-34f1ab389500 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Dr.Reddy's Laboratories Limited | a69542ea-5b6f-15c1-9e7a-90ac839971d3 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | NorthStar Rx LLC | 9ab07d6b-ae4a-a310-5572-b266676cd29e | 2025-11-20 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Advagen Pharma Limited | 4ca9d713-ab63-48bf-9386-29301a842e60 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Zydus Pharmaceuticals USA Inc. | e849033b-a3bc-408e-88de-7cd1d2660949 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Zydus Pharmaceuticals USA Inc. | eb436371-d188-4803-a864-07b90c357e57 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| LAMICTAL | LAMOTRIGINE | GlaxoSmithKline LLC | d7e3572d-56fe-4727-2bb4-013ccca22678 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE |
| LAMICTAL XR | LAMOTRIGINE | GlaxoSmithKline LLC | 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Zydus Lifesciences Limited | 0f2f7421-56d4-45d0-9d2d-dc1edaede039 | 2025-10-04 | Lamotrigine LAMOTRIGINE | |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 8e1e4fa8-881c-4618-88f6-018ab15db44d | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 53774022-ea0c-42a9-a720-dc755c77b851 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 3dfdcc2d-b7c5-7abf-e063-6394a90a24a6 | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | d33c4293-347c-49a1-9d98-f291c3dab6da | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Jubilant Cadista Pharmacuticals Inc. | 0b0f0209-edbd-46f3-9bed-762cbea0d737 | 2025-07-15 | 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 |
|---|---|---|---|---|---|
| 50090-2466 | LAMOTRIGINE | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-3171 | LAMOTRIGINE | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-3171 | LAMOTRIGINE | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-3278 | LAMOTRIGINE | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50436-0149 | LAMOTRIGINE | Lamotrigine | Unit Dose Services | ANDA | Current |
| 53002-1512 | LAMOTRIGINE | Lamotrigine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1512 | LAMOTRIGINE | Lamotrigine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1513 | LAMOTRIGINE | Lamotrigine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1513 | LAMOTRIGINE | Lamotrigine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 58118-2148 | LAMOTRIGINE | Lamotrigine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-2148 | LAMOTRIGINE | Lamotrigine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-2148 | LAMOTRIGINE | Lamotrigine | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-549 | LAMOTRIGINE | Lamotrigine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-744 | LAMOTRIGINE | Lamotrigine | Proficient Rx LP | ANDA | Current |
| 63187-744 | LAMOTRIGINE | Lamotrigine | Proficient Rx LP | ANDA | Current |
| 68788-6822 | LAMOTRIGINE | Lamotrigine | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-6822 | LAMOTRIGINE | Lamotrigine | Preferred Pharmaceuticals, Inc | ANDA | Current |
| 68788-7178 | LAMOTRIGINE | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7178 | LAMOTRIGINE | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7278 | LAMOTRIGINE | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7278 | LAMOTRIGINE | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69097-148 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-148 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-148 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-148 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-149 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-149 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-149 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-149 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-151 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-151 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-151 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-151 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-152 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-152 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-152 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 69097-152 | LAMOTRIGINE | Lamotrigine | Cipla USA Inc. | ANDA | Current |
| 70518-0001 | LAMOTRIGINE | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0001 | LAMOTRIGINE | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1480 | LAMOTRIGINE | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1480 | LAMOTRIGINE | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1602 | LAMOTRIGINE | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1602 | LAMOTRIGINE | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 71335-0010 | LAMOTRIGINE | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0044 | LAMOTRIGINE | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0044 | LAMOTRIGINE | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0057 | LAMOTRIGINE | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0276 | LAMOTRIGINE | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0276 | LAMOTRIGINE | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 76519-1150 | LAMOTRIGINE | LAMOTRIGINE | H. J. Harkins Company Inc. | ANDA | Current |
| 76519-1151 | LAMOTRIGINE | LAMOTRIGINE | H. J. Harkins Company Inc. | ANDA | Current |
| 76519-1165 | LAMOTRIGINE | LAMOTRIGINE | H. J. Harkins Company Inc. | ANDA | Current |