Application 076306
- Type
- ANDA
- Sponsor
- ROXANE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPIRAMATE | TOPIRAMATE | TABLET;ORAL | 25MG | No | No |
| 002 | TOPIRAMATE | TOPIRAMATE | TABLET;ORAL | 50MG | No | No |
| 003 | TOPIRAMATE | TOPIRAMATE | TABLET;ORAL | 100MG | No | No |
| 004 | TOPIRAMATE | TOPIRAMATE | TABLET;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076306-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | ||
| A076306-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | ||
| A076306-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | ||
| A076306-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 |
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 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076306-001 | TOPIRAMATE | 25MG | TABLET / ORAL | 2009-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076306-002 | TOPIRAMATE | 50MG | TABLET / ORAL | 2009-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076306-003 | TOPIRAMATE | 100MG | TABLET / ORAL | 2009-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076306-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 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 | Asclemed USA, Inc. | 4e476c33-3590-4c6f-981d-915623cdacf0 | 2022-09-09 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | e382a731-ef73-4990-bc74-ffc3a91ff3ba | 2022-06-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 57ac12ed-27f0-4f5c-96ae-a7433714b429 | 2022-05-02 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Aphena Pharma Solutions - Tennessee, LLC | 3b18b43c-0de2-4acf-b0d5-f1b601d496de | 2021-05-03 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | e9c4e279-0ef9-4e96-8741-dfe7556953d9 | 2021-01-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | a712d050-d5de-4685-a80a-548ab080fdb7 | 2021-01-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8 | 2020-09-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Proficient Rx LP | cc918c0d-2b1e-4fa0-b4d3-9dbc28718018 | 2020-02-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Proficient Rx LP | 584e16c5-5ffb-4bfc-ba80-4340afd25e8e | 2020-01-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 7d6752ce-7a56-4b04-ab15-cbd40aa5cc94 | 2019-11-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Proficient Rx LP | efc0d85e-fddc-4122-85b2-da2d2cb2f9d8 | 2019-11-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
| topiramate | TOPIRAMATE | Proficient Rx LP | 2d6d236b-9808-4e18-b521-e7435d1fd5cc | 2019-10-01 | Warnings, Adverse reactions | topiramate TOPIRAMATE |
| Topiramate | TOPIRAMATE | Sun Pharmaceutical Industries, Inc. | 2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef | 2018-11-01 | Warnings, Adverse reactions | Topiramate TOPIRAMATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23814 | ORIG | 2009-04-14 |