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 Kit | LAMOTRIGINE | OWP Pharmaceuticals, Inc. | 474fb321-575c-4b97-9dbe-080061652ee4 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE LAMOTRIGINE |
| SUBVENITE | LAMOTRIGINE | OWP Pharmaceuticals, Inc. | 7ad18b68-ba16-4810-9c3e-27fa970454e8 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Limited | 03610cdf-7eaa-445c-a441-ff17be5a7c68 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Rising Pharma Holdings, Inc. | f54690b3-bcbb-4d94-95b9-b7591af00117 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 260dc37d-6e64-4688-82dc-10a1a428af17 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Aurobindo Pharma Limited | e08920c2-04a3-4fb5-acc5-0af3140f82e9 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Torrent Pharmaceuticals Limited | 52df02a7-83da-4b20-9951-69790237dc24 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Inc. | df34faa4-829e-413a-a230-cbec604eead9 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | American Health Packaging | 6034a8b8-9e80-43ca-b84f-ea82f788268c | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Inc. | 05cba628-b12c-44d8-89a8-3522fe417cc1 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Alembic Pharmaceuticals Inc. | 4bd7193f-a81a-4909-90c2-7f324fc6ddfd | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| lamotrigine | LAMOTRIGINE EXTENDED-RELEASE | Camber Pharmaceuticals Inc | e45bd69f-3580-ff15-e053-2a95a90a4615 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | lamotrigine |
| Lamotrigine | LAMOTRIGINE | Glenmark Pharmaceuticals Inc., USA | 50fcf452-2d21-493e-a1dd-0c6ea9ac6184 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine Extended-Release | LAMOTRIGINE | Par Health USA, LLC | d5ec4d58-c669-4ab4-ba62-b71007536854 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals Inc. | 634dbe6c-4874-4d54-aa25-be02d3341f16 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | AvKARE | a63e19c0-a093-e896-e053-2a95a90a7ccd | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | NuCare Pharmaceuticals, Inc. | 47fd2592-2fc6-9787-e063-6394a90a8f01 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Quallent Pharmaceuticals Health LLC | 7977c87f-b459-486a-9edc-0a2071c46f4c | 2026-01-03 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Northwind Health Company, LLC | 03fd8413-df56-50ab-e063-6394a90a6950 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Lamotrigine LAMOTRIGINE |
| Lamotrigine | LAMOTRIGINE | Northwind Health Company, LLC | db5f7ee5-9bd9-1819-e053-2a95a90a91df | 2026-01-01 | 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 |