Application 090170
- Type
- ANDA
- Sponsor
- UNICHEM LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A090170-001 | LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | |
| A090170-002 | LAMOTRIGINE | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | |
| A090170-003 | LAMOTRIGINE | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | |
| A090170-004 | LAMOTRIGINE | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090170-001 | AB |
| A090170-002 | AB |
| A090170-003 | AB |
| A090170-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-001 | LAMOTRIGINE | 25MG | TABLET / ORAL | AB | 2011-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-002 | LAMOTRIGINE | 100MG | TABLET / ORAL | AB | 2011-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-003 | LAMOTRIGINE | 150MG | TABLET / ORAL | AB | 2011-10-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-004 | LAMOTRIGINE | 200MG | TABLET / ORAL | AB | 2011-10-06 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090170-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090170-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090170-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090170-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A090170-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090170-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090170-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090170-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090170-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090170-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090170-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090170-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090170-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090170-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090170-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090170-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090170-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090170-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090170-004 | AB | 1 | 2680178bc6a6… |
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 | Proficient Rx LP | 6f7e59d2-4311-42a0-93a0-b29b0417d96f | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Proficient Rx LP | 52273d60-3f27-4846-bf40-014ebcf09417 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 71205-245 |
| Lamotrigine | LAMOTRIGINE | Proficient Rx LP | b94ae2e4-e276-40c1-bc25-da980194fc99 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 |
| Lamotrigine | LAMOTRIGINE | Asclemed USA, Inc. | 8ac9dc83-edb2-4ae5-8064-40f113fd3aab | 2020-10-14 | Boxed warning, Warnings, Adverse reactions | 090170 ANDA090170 76420-182 |
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 |
|---|---|---|---|---|---|
| 68788-7223 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7544 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7544 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7544 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7544 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7647 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7647 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7647 | Lamotrigine | Lamotrigine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1479 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1479 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1479 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1479 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1479 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1908 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1978 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1978 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1978 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1978 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2343 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2406 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2406 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2406 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2577 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70518-2577 | Lamotrigine | Lamotrigine | REMEDYREPACK INC. | ANDA | Current |
| 70934-975 | Lamotrigine | Lamotrigine | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-245 | Lamotrigine | Lamotrigine | Proficient Rx LP | ANDA | Current |
| 71205-245 | Lamotrigine | Lamotrigine | Proficient Rx LP | ANDA | Current |
| 71205-245 | Lamotrigine | Lamotrigine | Proficient Rx LP | ANDA | Current |
| 71205-245 | Lamotrigine | Lamotrigine | Proficient Rx LP | ANDA | Current |
| 71335-0706 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0706 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0706 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0706 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0830 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0830 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0830 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0830 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0830 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1110 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1110 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1110 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1110 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1110 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1179 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1179 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1179 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1179 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 71335-1179 | Lamotrigine | Lamotrigine | Bryant Ranch Prepack | ANDA | Current |
| 72189-063 | LAMOTRIGINE | LAMOTRIGINE | DIRECT RX | ANDA | Current |
| 72789-206 | Lamotrigine | Lamotrigine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-206 | Lamotrigine | Lamotrigine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 76420-182 | Lamotrigine | Lamotrigine | Asclemed USA, Inc. | ANDA | Current |