Application 077627
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
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 |
|---|---|---|---|---|---|---|---|
| A077627-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A077627-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A077627-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A077627-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077627-001 | AB |
| A077627-002 | AB |
| A077627-003 | AB |
| A077627-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077627-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077627-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077627-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077627-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077627-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077627-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077627-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077627-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077627-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077627-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077627-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077627-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077627-004 | AB | 1 | d8e5a09893c0… |
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. | 610d4df7-703f-4070-9adc-3e57ca05a2f1 | 2026-07-31 | Warnings, Adverse reactions | 077627 ANDA077627 70518-2955 |
| Topiramate | TOPIRAMATE | Unit Dose Solutions, Inc. | 562f3fec-489b-4662-e063-6294a90a4ea2 | 2026-07-09 | Warnings, Adverse reactions | 077627 ANDA077627 |
| Topiramate | TOPIRAMATE | Glenmark Pharmaceuticals Inc., USA | 35312f49-decf-428d-bf5f-4215b762ed3c | 2026-04-10 | Warnings, Adverse reactions | 077627 ANDA077627 68462-109 68462-108 68462-110 68462-153 |
| Topiramate | TOPIRAMATE | Northwind Health Company, LLC | ae63e0e2-ceb1-4cc7-88fa-92cfa4516960 | 2026-01-01 | Warnings, Adverse reactions | 077627 ANDA077627 51655-608 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 3f99b26b-79b9-4efb-aa2c-2868e1e126c8 | 2025-08-05 | Warnings, Adverse reactions | 077627 ANDA077627 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | a712d050-d5de-4685-a80a-548ab080fdb7 | 2021-01-01 | Warnings, Adverse reactions | 077627 ANDA077627 63187-118 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8 | 2020-09-01 | Warnings, Adverse reactions | 077627 ANDA077627 63187-283 63187-479 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8138 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8138 | Topiramate | Topiramate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8138 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8139 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8139 | Topiramate | Topiramate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8139 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8140 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8140 | Topiramate | Topiramate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8140 | Topiramate | Topiramate | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-489 | Topiramate | Topiramate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-847 | Topiramate | Topiramate | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-106 | Topiramate | Topiramate | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43063-573 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-573 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-573 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-573 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-573 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-605 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-605 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-605 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-605 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-605 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-612 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-612 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-612 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-612 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-612 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 51655-032 | TOPIRAMATE | TOPIRAMATE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-608 | TOPIRAMATE | TOPIRAMATE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-609 | Topiramate | Topiramate | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 63187-118 | Topiramate | Topiramate | Proficient Rx LP | ANDA | Current |
| 63187-118 | Topiramate | Topiramate | Proficient Rx LP | ANDA | Current |
| 63187-283 | Topiramate | Topiramate | Proficient Rx LP | ANDA | Current |
| 63187-283 | Topiramate | Topiramate | Proficient Rx LP | ANDA | Current |
| 63187-479 | Topiramate | Topiramate | Proficient Rx LP | ANDA | Current |
| 63187-479 | Topiramate | Topiramate | Proficient Rx LP | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-108 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-109 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-110 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-153 | Topiramate | Topiramate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68788-6366 | Topiramate | Topiramate | Preferred Pharmaceuticalc | ANDA | Current |
| 68788-8967 | Topiramate | Topiramate | Preferred Pharmaceuticals | ANDA | Current |
| 70518-2899 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2899 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2955 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2955 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3067 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3067 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23878 | ORIG | 2009-04-14 |