Application 020241
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 100MG | Yes | No |
| 002 | LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 150MG | Yes | No |
| 003 | LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 200MG | Yes | No |
| 004 | LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 25MG | Yes | Yes |
| 006 | LAMICTAL | LAMOTRIGINE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020241-001 | LAMICTAL | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 |
| N020241-002 | LAMICTAL | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 |
| N020241-003 | LAMICTAL | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 |
| N020241-004 | LAMICTAL | LAMOTRIGINE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | |
| N020241-005 | LAMICTAL | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | RLD | 1994-12-27 |
| N020241-006 | LAMICTAL | LAMOTRIGINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020241-001 | AB |
| N020241-002 | AB |
| N020241-003 | AB |
| N020241-005 | 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 | N020241-001 | LAMICTAL | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-002 | LAMICTAL | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-003 | LAMICTAL | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-004 | LAMICTAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-005 | LAMICTAL | 25MG | TABLET / ORAL | AB | RLD, RS | 1994-12-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-006 | LAMICTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-001 | LAMICTAL | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-002 | LAMICTAL | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-003 | LAMICTAL | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-004 | LAMICTAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-005 | LAMICTAL | 25MG | TABLET / ORAL | AB | RLD, RS | 1994-12-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-006 | LAMICTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-001 | LAMICTAL | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-002 | LAMICTAL | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-003 | LAMICTAL | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-004 | LAMICTAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-005 | LAMICTAL | 25MG | TABLET / ORAL | AB | RLD, RS | 1994-12-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-006 | LAMICTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-001 | LAMICTAL | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-002 | LAMICTAL | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-003 | LAMICTAL | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-004 | LAMICTAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-005 | LAMICTAL | 25MG | TABLET / ORAL | AB | RLD, RS | 1994-12-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-006 | LAMICTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-001 | LAMICTAL | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-002 | LAMICTAL | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-003 | LAMICTAL | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-004 | LAMICTAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-005 | LAMICTAL | 25MG | TABLET / ORAL | AB | RLD, RS | 1994-12-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-006 | LAMICTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-001 | LAMICTAL | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-002 | LAMICTAL | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-003 | LAMICTAL | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-004 | LAMICTAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-005 | LAMICTAL | 25MG | TABLET / ORAL | AB | RLD, RS | 1994-12-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-006 | LAMICTAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-001 | LAMICTAL | 100MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-002 | LAMICTAL | 150MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-003 | LAMICTAL | 200MG | TABLET / ORAL | AB | RLD | 1994-12-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-004 | LAMICTAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1994-12-27 | 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 | N020241-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020241-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020241-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020241-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020241-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020241-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020241-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020241-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020241-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020241-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020241-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020241-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020241-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020241-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020241-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020241-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020241-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020241-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020241-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020241-005 | 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 |
|---|---|---|---|---|---|---|
| LAMICTAL | LAMOTRIGINE | GlaxoSmithKline LLC | d7e3572d-56fe-4727-2bb4-013ccca22678 | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 020241 NDA020241 0173-0633 0173-0594 0173-0817 0173-0642 0173-0644 0173-0643 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0594 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0594 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0594 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0594 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0594 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0594 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0594 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0633 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0633 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0633 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0633 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0633 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0633 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0633 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0642 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0642 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0642 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0642 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0642 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0642 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0642 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0643 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0643 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0643 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0643 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0643 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0643 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0643 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0644 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0644 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0644 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0644 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0644 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0644 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0644 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0817 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0817 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0817 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0817 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0817 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0817 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0817 | LAMICTAL | lamotrigine | GlaxoSmithKline LLC | NDA | Current |
| 21695-223 | LAMICTAL | lamotrigine | Rebel Distributors Corp | NDA | Current |
| 21695-224 | LAMICTAL | lamotrigine | Rebel Distributors Corp | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, In | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-410 | LAMICTAL | lamotrigine | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 70518-0049 | LAMICTAL | lamotrigine | REMEDYREPACK INC. | NDA | Current |
| 70518-0049 | LAMICTAL | lamotrigine | REMEDYREPACK INC. | NDA | Current |
| 70518-0049 | LAMICTAL | lamotrigine | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83762 | SUPPL | 2025-10-15 |
| 83737 | SUPPL | 2025-10-14 |
| 83736 | SUPPL | 2025-10-14 |
| 83735 | SUPPL | 2025-10-14 |
| 82111 | SUPPL | 2025-05-01 |
| 82110 | SUPPL | 2025-05-01 |
| 82043 | SUPPL | 2025-04-29 |
| 82042 | SUPPL | 2025-04-29 |
| 66966 | SUPPL | 2021-04-01 |
| 66965 | SUPPL | 2021-04-01 |
| 66940 | SUPPL | 2021-04-01 |
| 64912 | SUPPL | 2020-10-14 |
| 64911 | SUPPL | 2020-10-14 |
| 64900 | SUPPL | 2020-10-14 |
| 64561 | SUPPL | 2020-09-11 |
| 64556 | SUPPL | 2020-09-11 |
| 64555 | SUPPL | 2020-09-11 |
| 64514 | SUPPL | 2020-09-04 |
| 64513 | SUPPL | 2020-09-04 |
| 64470 | SUPPL | 2020-09-01 |
| 64310 | SUPPL | 2020-08-19 |
| 60130 | SUPPL | 2019-09-26 |
| 60129 | SUPPL | 2019-09-26 |
| 60117 | SUPPL | 2019-09-26 |
| 59714 | SUPPL | 2019-08-15 |
| 59707 | SUPPL | 2019-08-15 |
| 54979 | SUPPL | 2018-07-26 |
| 54959 | SUPPL | 2018-07-24 |
| 54846 | SUPPL | 2018-07-06 |
| 54753 | SUPPL | 2018-07-05 |
| 12367 | SUPPL | 2015-05-21 |
| 24652 | SUPPL | 2015-05-20 |
| 12366 | SUPPL | 2015-03-25 |
| 12365 | SUPPL | 2015-03-25 |
| 2239 | SUPPL | 2015-03-25 |
| 2237 | SUPPL | 2015-03-25 |
| 24646 | SUPPL | 2015-01-07 |
| 24642 | SUPPL | 2015-01-07 |
| 34421 | SUPPL | 2015-01-05 |
| 12362 | SUPPL | 2015-01-05 |
| 34426 | SUPPL | 2014-06-30 |
| 24651 | SUPPL | 2014-06-12 |
| 2235 | SUPPL | 2013-12-26 |
| 34420 | SUPPL | 2013-12-23 |
| 41228 | SUPPL | 2013-09-06 |
| 34417 | SUPPL | 2013-09-06 |
| 24641 | SUPPL | 2013-09-06 |
| 12361 | SUPPL | 2013-09-06 |
| 12360 | SUPPL | 2013-09-06 |
| 12359 | SUPPL | 2013-09-06 |
| 2234 | SUPPL | 2013-09-06 |
| 2233 | SUPPL | 2013-09-06 |
| 2232 | SUPPL | 2013-09-06 |
| 34425 | SUPPL | 2012-08-02 |
| 24650 | SUPPL | 2012-08-02 |
| 34424 | SUPPL | 2011-12-02 |
| 24649 | SUPPL | 2011-12-02 |
| 24648 | SUPPL | 2011-08-08 |
| 34423 | SUPPL | 2011-08-05 |
| 2238 | SUPPL | 2011-06-02 |
| 24647 | SUPPL | 2010-11-03 |
| 2236 | SUPPL | 2010-11-03 |
| 34422 | SUPPL | 2010-10-28 |
| 12364 | SUPPL | 2010-10-28 |
| 34418 | SUPPL | 2009-07-08 |
| 24643 | SUPPL | 2009-05-13 |
| 34419 | SUPPL | 2009-05-12 |
| 12363 | SUPPL | 2009-05-12 |
| 24645 | SUPPL | 2009-05-04 |
| 24644 | SUPPL | 2009-05-04 |
| 41227 | SUPPL | 2007-05-29 |
| 24638 | SUPPL | 2006-09-27 |
| 12358 | SUPPL | 2006-09-26 |
| 34414 | SUPPL | 2006-09-25 |
| 41226 | SUPPL | 2005-12-08 |
| 2231 | SUPPL | 2004-01-22 |
| 34416 | SUPPL | 2003-07-08 |
| 24639 | SUPPL | 2003-07-06 |
| 24640 | SUPPL | 2003-04-18 |
| 34413 | SUPPL | 2003-03-06 |
| 34415 | SUPPL | 2001-05-25 |
| 20552 | SUPPL | 1999-06-30 |
| 41225 | SUPPL | 1999-05-20 |
| 34412 | SUPPL | 1998-12-14 |
| 2230 | SUPPL | 1998-12-14 |
| 24637 | SUPPL | 1998-08-24 |
| 12357 | SUPPL | 1998-08-24 |
| 64535 | SUPPL | 1900-01-01 |
| 63722 | SUPPL | 1900-01-01 |
| 63721 | SUPPL | 1900-01-01 |
| 63720 | SUPPL | 1900-01-01 |