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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078235-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078235-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078235-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078235-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078235-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078235-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078235-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078235-004 | AB | 1 | caaa826d4ba7… |
| 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… |
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 | Northwind Health Company, LLC | ffd7be08-050e-dfcb-e053-6394a90ad286 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Cardinal Health 107, LLC | e5bc696e-040d-4d3e-b38c-9548a38fa936 | 2025-10-13 | Warnings, Adverse reactions | 078235 ANDA078235 55154-7142 55154-7146 |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | be42ed09-350c-4e8a-aff4-6afb242dd599 | 2025-10-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals, Inc. | 2b6b0642-fb91-4641-9c51-d3be2021992b | 2025-10-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| Topiramate | TOPIRAMATE | American Health Packaging | 1af94c80-2b17-409a-98f6-ce00f942351d | 2025-09-30 | Warnings, Adverse reactions | 078235 ANDA078235 68084-345 68084-343 68084-342 68084-344 |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | 83558f89-1adb-4d81-b19b-68721d48034b | 2025-09-30 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals, Inc. | d8454fdf-7b34-49c0-b130-732e39b774b2 | 2025-09-30 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Major Pharmaceuticals | 6fb00bd8-c49e-46ef-9d6b-1b602e1d11d8 | 2025-08-25 | Warnings, Adverse reactions | 078235 ANDA078235 0904-6928 0904-6929 |
| topiramate | TOPIRAMATE | A-S Medication Solutions | 674c2c2e-014a-43a1-91a7-7214ffc4b1d7 | 2025-08-13 | Warnings, Adverse reactions | 078235 ANDA078235 50090-5309 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | b353e7fb-b976-96d8-e053-2995a90a110a | 2024-08-14 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Zydus Lifesciences Limited | 57016639-89fe-43ad-89c4-5e7a756dddec | 2024-08-14 | 078235 ANDA078235 65841-648 65841-647 65841-649 65841-650 | |
| topiramate | TOPIRAMATE | NuCare Pharmaceuticals,Inc. | 87dc077b-2c84-522b-e053-2995a90a68bc | 2024-06-14 | Warnings, Adverse reactions | 078235 ANDA078235 68071-4877 |
| topiramate | TOPIRAMATE | Advanced Rx of Tennessee, LLC | 1a16d6a9-3dd1-ede8-e063-6294a90afe75 | 2024-06-04 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | A-S Medication Solutions | f7f2d1bc-9c65-4798-826f-6902b3ec81dc | 2023-11-24 | Warnings, Adverse reactions | 078235 ANDA078235 50090-5853 |
| topiramate | TOPIRAMATE | Proficient Rx LP | 80481455-7ad7-4f44-8113-b8b61d8581a0 | 2022-11-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
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 |
|---|---|---|---|---|---|
| 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 |