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 | 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 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 68a4dac2-5015-40c5-88ca-204098c3b288 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Coupler LLC | 52b8be5c-ef88-dfa7-e063-6394a90a0500 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Aurobindo Pharma Limited | a9a4309e-fe43-4a26-a30f-c6577d650336 | 2026-05-25 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Limited | ccb33cd0-e5f7-4a50-8b55-ad7c432cdb77 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Unichem Pharmaceuticals (USA), Inc. | 4b72ea7a-a0b0-4980-84ad-84f64e2e6368 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals, Inc. | 16323699-9bf8-43c7-b3aa-589156377872 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals Inc. | 09a0d30d-9b8f-4c76-8cdb-8492386b2254 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | AvKARE | fcdb94a8-33be-6375-98ef-6933999d157f | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Major Pharmaceuticals | 12e0be85-0961-4fe0-b973-83251ecf0f65 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Actavis Pharma, Inc. | 87beaf22-593d-4170-bb58-332c615ef90d | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| LAMOTRIGINE | LAMOTRIGINE | Sun Pharmaceutical Industries, Inc. | 83297e2e-9199-4b3d-9f44-a921787758fe | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| lamotrigine | LAMOTRIGINE EXTENDED-RELEASE | REMEDYREPACK INC. | 65748114-c59c-4ebb-977e-d4aab5764dd3 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | lamotrigine |
| Lamotrigine | LAMOTRIGINE | Par Health USA, LLC | 003663e5-c0c7-4fc1-a64d-313f2a5b10d2 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Nordic Pharma, Inc. | 67cf961e-02b9-4a99-944f-43a55df6a544 | 2026-04-07 | 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 |