Application 077633
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 25MG | No | No |
| 002 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 50MG | No | No |
| 003 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 100MG | No | No |
| 004 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 150MG | No | No |
| 005 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 200MG | No | No |
| 006 | LAMOTRIGINE | LAMOTRIGINE | TABLET;ORAL | 250MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077633-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | |
| A077633-002 | LAMOTRIGINE | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | ||
| A077633-003 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | |
| A077633-004 | LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | |
| A077633-005 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | |
| A077633-006 | LAMOTRIGINE | LAMOTRIGINE | 250MG | TABLET / ORAL | 2009-01-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077633-001 | AB |
| A077633-003 | AB |
| A077633-004 | AB |
| A077633-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077633-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077633-002 | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077633-003 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077633-004 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077633-005 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077633-006 | LAMOTRIGINE | 250MG | TABLET / ORAL | 2009-01-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-002 | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-003 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-004 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-005 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-006 | LAMOTRIGINE | 250MG | TABLET / ORAL | 2009-01-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077633-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-002 | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077633-003 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-004 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-005 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-006 | LAMOTRIGINE | 250MG | TABLET / ORAL | 2009-01-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-002 | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-003 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-004 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-005 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-006 | LAMOTRIGINE | 250MG | TABLET / ORAL | 2009-01-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-002 | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-003 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-004 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-005 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-006 | LAMOTRIGINE | 250MG | TABLET / ORAL | 2009-01-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-002 | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-003 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-004 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-005 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2009-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-006 | LAMOTRIGINE | 250MG | TABLET / ORAL | 2009-01-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2009-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-002 | LAMOTRIGINE | 50MG | TABLET / ORAL | 2009-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-003 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2009-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-004 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2009-01-27 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077633-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077633-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077633-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077633-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077633-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077633-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077633-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077633-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077633-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077633-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077633-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077633-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077633-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077633-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077633-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077633-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077633-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077633-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077633-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077633-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077633-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077633-005 | AB | 1 | d06236e962d9… |
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 | American Health Packaging | 35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 68084-318 68084-319 |
| Lamotrigine | LAMOTRIGINE | REMEDYREPACK INC. | 15d801a0-f0a5-40c1-bc88-d5ba9a02c696 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | Cardinal Health 107, LLC | 20e156df-a2b6-4710-b526-0419cd17dd33 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 55154-2065 |
| Lamotrigine | LAMOTRIGINE | Major Pharmaceuticals | 12e0be85-0961-4fe0-b973-83251ecf0f65 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 0904-7007 0904-7008 |
| Lamotrigine | LAMOTRIGINE | American Health Packaging | 6034a8b8-9e80-43ca-b84f-ea82f788268c | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 60687-693 60687-704 |
| Lamotrigine | LAMOTRIGINE | Preferred Pharmaceuticals Inc. | 634dbe6c-4874-4d54-aa25-be02d3341f16 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | Quallent Pharmaceuticals Health LLC | 7977c87f-b459-486a-9edc-0a2071c46f4c | 2026-01-03 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | Northwind Health Company, LLC | 03fd8413-df56-50ab-e063-6394a90a6950 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | Northstar Rx LLC. | aabc64fe-1f17-4140-81f2-7d4506db6c8b | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 16714-195 16714-194 16714-197 16714-196 |
| Lamotrigine | LAMOTRIGINE | Cardinal Health 107, LLC | beb24a4f-ab0b-435a-b60b-2b8d565ecd75 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 55154-2331 55154-2330 |
| Lamotrigine | LAMOTRIGINE | Zydus Pharmaceuticals USA Inc. | e849033b-a3bc-408e-88de-7cd1d2660949 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | Zydus Lifesciences Limited | 0f2f7421-56d4-45d0-9d2d-dc1edaede039 | 2025-10-04 | 077633 ANDA077633 65841-683 65841-686 65841-685 65841-687 65841-684 65841-682 | |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 2cf33586-e48a-4b4e-b14b-33de2be63c1d | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | 4bbc140c-6092-416d-865d-49b89c5ecdd0 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | Bryant Ranch Prepack | cf03f130-067f-401c-8501-0d78a989a319 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | NuCare Pharmaceuticals,Inc. | 065e97c9-3c5f-16e6-e063-6294a90a13fc | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 |
| Lamotrigine | LAMOTRIGINE | NCS HealthCare of KY, LLC dba Vangard Labs | e243e803-e95f-47a6-a6da-5fed657f4462 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 0615-7975 0615-8267 0615-8150 0615-7964 |
| Lamotrigine | LAMOTRIGINE | A-S Medication Solutions | 5a9575bb-230e-46ae-b58e-41554bad45eb | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 077633 ANDA077633 50090-5850 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-7964 | Lamotrigine | Lamotrigine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7975 | Lamotrigine | Lamotrigine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8150 | Lamotrigine | Lamotrigine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8267 | lamotrigine | lamotrigine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-7007 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 0904-7007 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 0904-7007 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 0904-7007 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 0904-7008 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 0904-7008 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 0904-7008 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 0904-7008 | Lamotrigine | Lamotrigine | Major Pharmaceuticals | ANDA | Current |
| 16714-194 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 16714-194 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 16714-195 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 16714-195 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 16714-196 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 16714-196 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 16714-197 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 16714-197 | Lamotrigine | Lamotrigine | Northstar Rx LLC. | ANDA | Current |
| 50090-2814 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-2825 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-4939 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-5567 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-5827 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-5828 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 50090-5850 | Lamotrigine | Lamotrigine | A-S Medication Solutions | ANDA | Current |
| 55154-2065 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 55154-2065 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 55154-2065 | Lamotrigine | Lamotrigine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-2065 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 55154-2330 | Lamotrigine | Lamotrigine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-2330 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 55154-2331 | Lamotrigine | Lamotrigine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-2331 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 55154-8137 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 55154-8137 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 55154-8142 | Lamotrigine | Lamotrigine | Cardinal Health | ANDA | Current |
| 60687-693 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 60687-704 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 60760-474 | Lamotrigine | Lamotrigine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63739-179 | Lamotrigine | Lamotrigine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-179 | Lamotrigine | Lamotrigine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-670 | Lamotrigine | Lamotrigine | McKesson Corporation | ANDA | Current |
| 63739-670 | Lamotrigine | Lamotrigine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-670 | Lamotrigine | Lamotrigine | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 65084-179 | Lamotrigine | Lamotrigine | McKesson Corporation dba RX Pak | ANDA | Current |
| 65084-179 | Lamotrigine | Lamotrigine | McKesson Corporation dba RX Pak | ANDA | Current |
| 65841-682 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-682 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-682 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-682 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-683 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-683 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-683 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-683 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-684 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-684 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-684 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-684 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-685 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-685 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-685 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-685 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-686 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-686 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-686 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-686 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-687 | Lamotrigine | Lamotrigine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-687 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-687 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 65841-687 | Lamotrigine | Lamotrigine | Cadila Healthcare Limited | ANDA | Current |
| 68084-318 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 68084-318 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 68084-318 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 68084-318 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 68084-318 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 68084-319 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 68084-319 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
| 68084-319 | Lamotrigine | Lamotrigine | American Health Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22607 | ORIG | 2012-02-14 |