Application 217248
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | No | No |
| 002 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 003 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 004 | TOPIRAMATE | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217248-001 | TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | |
| A217248-002 | TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | |
| A217248-003 | TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | |
| A217248-004 | TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217248-001 | AB1 |
| A217248-002 | AB1 |
| A217248-003 | AB1 |
| A217248-004 | AB1 |
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 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-06-20 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217248-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217248-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217248-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217248-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217248-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217248-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217248-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217248-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217248-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217248-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217248-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217248-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217248-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217248-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217248-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217248-004 | AB1 | 1 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | c320999e-b940-44d8-bf31-2fb78835ac2d | 2025-05-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | ea0bcab1-cfe1-491c-875e-8c865449557e | 2025-04-29 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 073d075d-d019-4834-b55d-9b9587914975 | 2025-04-16 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Cipla USA Inc. | 4087eb3c-96e9-4d0a-b80b-663e1c86d256 | 2025-04-14 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | EXELAN PHARMACEUTICALS INC. | 690baf58-1ec9-463e-99b7-d601362ea56b | 2025-04-14 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Cipla USA Inc. | ca4ec248-285d-4066-8f89-5ed0c538c4c9 | 2025-04-09 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Advanced Rx of Tennessee, LLC | 30ca2fce-4e4c-439e-e063-6294a90af076 | 2025-03-20 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | bbf0f882-1dcc-415d-82bb-acc64f4dc2bc | 2025-02-21 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | 288d6b40-8c87-4f16-85a7-86166b5ac77f | 2025-02-14 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Advanced Rx of Tennessee, LLC | 2cf7ce9e-afc2-f94e-e063-6394a90a35d0 | 2025-01-30 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | 521be3f1-3ee7-45c7-9f0c-17e08b6c8fca | 2025-01-21 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | d63b64dd-b420-4283-9bac-92ba43c9f429 | 2025-01-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | eca774cf-2e4e-7642-e053-2a95a90a847d | 2024-12-31 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | d8dff98f-185e-77ba-e053-2995a90aed2f | 2024-12-31 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | f16065c0-9949-9ac4-e053-2995a90a3b02 | 2024-12-31 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | f781ada8-f90d-b233-e053-6394a90a87ff | 2024-12-31 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Zydus Lifesciences Limited | 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b | 2024-10-25 | topiramate TOPIRAMATE | |
| topiramate | TOPIRAMATE | A-S Medication Solutions | 8706a35d-5c39-4daf-b83a-65f3d630e043 | 2024-08-21 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 61390be3-7553-4cb5-b5da-7571ed7d4b17 | 2024-08-20 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | ffaacad8-4594-45a8-b292-02a84cd0c35b | 2024-08-20 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.