Application 078235
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
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 |
|---|---|---|---|---|---|---|---|
| A078235-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078235-001 | AB |
| A078235-002 | AB |
| A078235-003 | AB |
| A078235-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078235-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-004 | 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 |
|---|---|---|---|---|---|---|
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 7e0834ee-920b-496f-954d-f9d81c3ba2d6 | 2026-07-17 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0366164b-1846-443d-9564-dbe52d8d9b65 | 2026-07-08 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 92637f92-9d7c-c246-e053-2995a90a0347 | 2026-06-26 | Warnings, Adverse reactions | 078235 ANDA078235 60760-577 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 9221403c-467f-738e-e053-2995a90ac8fd | 2026-06-26 | Warnings, Adverse reactions | 078235 ANDA078235 60760-075 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 8abe45eb-cc75-4625-ae3d-5b2a038c4907 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | bffcd213-4f09-4a5b-8ccb-591a68be402b | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 57462baf-2f32-4bde-9627-2214c8af9370 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Coupler LLC | 5461f33d-eaef-dce3-e063-6294a90aeff8 | 2026-06-16 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | AvPAK | 53c3f980-f05b-c671-e063-6294a90a77d5 | 2026-06-09 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 6f461f84-bfad-44fa-a2bd-5ea1566444b5 | 2026-05-21 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | b7539f52-06e9-4663-b401-92f5f83653cc | 2026-05-21 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 5ce65b7f-9215-47a8-a784-f87a810bd7e4 | 2026-05-19 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db | 2026-05-19 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 149d20de-f262-4567-aa97-d4d28a1653cb | 2026-04-30 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Quallent Pharmaceuticals Health LLC | 9dae6824-6913-42de-b98a-cdcb0d3b4a46 | 2026-04-25 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Zydus Pharmaceuticals USA Inc. | 67dcdd6e-48bc-418e-a887-805929d83ce0 | 2026-04-15 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | afd4c2b9-b80c-b43a-e053-2995a90ac923 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 51655-429 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | f3321dc5-0fb7-0d12-e053-2a95a90a9694 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | ffd7be08-050e-dfcb-e053-6394a90ad286 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-7562 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7563 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7564 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7565 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6928 | topiramate | topiramate | Major Pharmaceuticals | ANDA | Current |
| 0904-6928 | topiramate | topiramate | Major Pharmaceuticals | ANDA | Current |
| 0904-6929 | topiramate | topiramate | Major Pharmaceuticals | ANDA | Current |
| 0904-6929 | topiramate | topiramate | Major Pharmaceuticals | ANDA | Current |
| 45865-963 | topiramate | topiramate | medsource pharmaceuticals | ANDA | Current |
| 50090-3926 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3926 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3926 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3926 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-5309 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-5309 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-5309 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-5853 | topiramate | topiramate | A-S Medication Solutions | ANDA | Current |
| 50436-0139 | topiramate | topiramate | Unit Dose Services | ANDA | Current |
| 51655-429 | topiramate | topiramate | Northwind Pharmaceuticals | ANDA | Current |
| 51655-429 | topiramate | topiramate | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0921 | topiramate | topiramate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1132 | topiramate | topiramate | DOH CENTRAL PHARMACY | ANDA | Current |
| 55154-7142 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55154-7142 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55154-7142 | topiramate | topiramate | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7142 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55154-7142 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55154-7146 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55154-7146 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55154-7146 | topiramate | topiramate | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7146 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55154-7146 | topiramate | topiramate | Cardinal Health | ANDA | Current |
| 55700-210 | Topiramate | Topiramate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-075 | topiramate | topiramate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-514 | topiramate | topiramate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-577 | topiramate | topiramate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-577 | topiramate | topiramate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-577 | topiramate | topiramate | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 61919-883 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-883 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-883 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-883 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 63629-8189 | topiramate | topiramate | Bryant Ranch Prepack | ANDA | Current |
| 65841-647 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-647 | topiramate | topiramate | Zydus Lifesciences Limited | ANDA | Current |
| 65841-647 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-647 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-648 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-648 | topiramate | topiramate | Zydus Lifesciences Limited | ANDA | Current |
| 65841-648 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-648 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-649 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-649 | topiramate | topiramate | Zydus Lifesciences Limited | ANDA | Current |
| 65841-649 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-649 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-650 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-650 | topiramate | topiramate | Zydus Lifesciences Limited | ANDA | Current |
| 65841-650 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 65841-650 | topiramate | topiramate | Cadila Healthcare Limited | ANDA | Current |
| 68071-4756 | topiramate | topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4756 | topiramate | topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4793 | topiramate | topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4793 | topiramate | topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4877 | topiramate | topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4877 | topiramate | topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-342 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-342 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-342 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-342 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-342 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-343 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-343 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-343 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-344 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-344 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-344 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-344 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-344 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-345 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
| 68084-345 | Topiramate | Topiramate | American Health Packaging | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44379 | ORIG | 2009-04-14 |