Application 077650
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 25MG | No | No |
| 002 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 50MG | No | No |
| 003 | ZONISAMIDE | ZONISAMIDE | CAPSULE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077650-001 | ZONISAMIDE | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | ||
| A077650-002 | ZONISAMIDE | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | ||
| A077650-003 | ZONISAMIDE | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 |
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 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077650-002 | ZONISAMIDE | 50MG | CAPSULE / ORAL | 2006-04-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077650-003 | ZONISAMIDE | 100MG | CAPSULE / ORAL | 2006-04-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077650-001 | ZONISAMIDE | 25MG | CAPSULE / ORAL | 2006-04-20 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Zonisamide | ZONISAMIDE | Advanced Rx of Tennessee, LLC | 0bc550a7-09a7-75e4-e063-6294a90a9fc1 | 2024-12-31 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| zonisamide | ZONISAMIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 226d917a-33de-48cc-baf6-bd6a20668341 | 2024-10-23 | Warnings, Adverse reactions | zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Zydus Lifesciences Limited | 4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f | 2024-08-16 | Zonisamide ZONISAMIDE | |
| Zonisamide | ZONISAMIDE | American Health Packaging | 7cdd96c4-3263-4c28-86c0-3c24bcef16c1 | 2024-05-30 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Advanced Rx Pharmacy of Tennessee, LLC | 19b059f0-a08a-f75a-e063-6294a90a57db | 2024-05-30 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Viona Pharmaceuticals Inc | 5ab5b6aa-4bdc-4ec6-ba23-44caf2db953e | 2023-11-10 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| zonisamide | ZONISAMIDE | Bryant Ranch Prepack | 64bd9d6f-8cc0-4151-a78d-9f1437b36875 | 2023-10-24 | Warnings, Adverse reactions | zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Bryant Ranch Prepack | 2d569c8a-844b-44a8-81df-3f9c9300a79c | 2023-04-06 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Proficient Rx LP | b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1 | 2022-12-01 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Unichem Pharmaceuticals (USA), Inc. | 3c53d5e4-f47f-46fd-aa1c-158fd49ba9c0 | 2022-11-30 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Proficient Rx LP | 85321a9a-08d9-49e4-8c79-86ecfc536613 | 2022-10-01 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Proficient Rx LP | 812582ce-fc7e-44b1-a428-7faa3701c1b8 | 2022-04-01 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
| Zonisamide | ZONISAMIDE | Exelan Pharmaceuticals, Inc. | 24284954-0c29-458f-a9f8-97a7ad418ca7 | 2021-07-06 | Warnings, Adverse reactions | Zonisamide ZONISAMIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44626 | ORIG | 2008-02-01 |