Application 090278
- Type
- ANDA
- Sponsor
- SUN PHARM
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 |
|---|---|---|---|---|---|---|---|
| A090278-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A090278-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A090278-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A090278-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090278-001 | AB |
| A090278-002 | AB |
| A090278-003 | 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 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-004 | 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 | A090278-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090278-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090278-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090278-003 | AB | 1 | 79d66fd596c7… |
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 | PD-Rx Pharmaceuticals, Inc. | e846124d-e9e6-42c7-83f1-5df170d3f70b | 2026-07-07 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 47ef2964-3a41-4bfd-86fb-d44560b9961f | 2026-06-24 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 484c132f-3d3d-4218-b22f-82e9b56cc2f4 | 2026-06-24 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 1b847969-2124-4350-94b0-ef5ba707673b | 2026-06-08 | Warnings, Adverse reactions | 090278 ANDA090278 43063-997 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 021005ab-6a00-40d8-9aee-20c91613b4d5 | 2026-06-08 | Warnings, Adverse reactions | 090278 ANDA090278 43063-998 |
| Topiramate | TOPIRAMATE | Sun Pharmaceutical Industries, Inc. | 3c909a53-ae66-4b28-a741-b60bb25a69cf | 2026-06-01 | Warnings, Adverse reactions | 090278 ANDA090278 47335-711 47335-707 47335-710 47335-712 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 61390be3-7553-4cb5-b5da-7571ed7d4b17 | 2024-08-20 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | ffaacad8-4594-45a8-b292-02a84cd0c35b | 2024-08-20 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | NuCare Pharmaceuticals,Inc. | 9ddb8451-a455-87ec-e053-2995a90a5e5e | 2024-06-20 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 8bd03bb2-3b9b-4707-a9a4-5618ddc3832f | 2023-07-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| TOPIRAMATE | TOPIRAMATE | Proficient Rx LP | a30c583a-4b0a-43a6-ae76-19b1a5e916ca | 2022-10-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | e382a731-ef73-4990-bc74-ffc3a91ff3ba | 2022-06-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 7d6752ce-7a56-4b04-ab15-cbd40aa5cc94 | 2019-11-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Sun Pharmaceutical Industries, Inc. | 2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef | 2018-11-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 12634-083 | Topiramate | Topiramate | Apotheca Inc. | ANDA | Current |
| 12634-452 | Topiramate | Topiramate | Apotheca Inc. | ANDA | Current |
| 12634-453 | Topiramate | Topiramate | Apotheca Inc. | ANDA | Current |
| 21695-162 | TOPIRAMATE | TOPIRAMATE | Rebel Distributors Corp | ANDA | Current |
| 21695-205 | TOPIRAMATE | TOPIRAMATE | Rebel Distributors Corp | ANDA | Current |
| 21695-348 | TOPIRAMATE | TOPIRAMATE | Rebel Distributors Corp | ANDA | Current |
| 21695-349 | TOPIRAMATE | TOPIRAMATE | Rebel Distributors Corp | ANDA | Current |
| 43063-997 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-997 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-997 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-997 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-997 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-997 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-997 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-998 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-998 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-998 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-998 | Topiramate | Topiramate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-551 | Topiramate | Topiramate | medsource pharmaceuticals | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-707 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-710 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-711 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-712 | Topiramate | Topiramate | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 50090-3752 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3752 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3752 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3931 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3931 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3931 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3932 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50090-3932 | Topiramate | Topiramate | A-S Medication Solutions | ANDA | Current |
| 50436-9952 | Topiramate | Topiramate | Unit Dose Services | ANDA | Current |
| 52959-643 | TOPIRAMATE | TOPIRAMATE | H.J. Harkins Company, Inc. | ANDA | Current |
| 53808-0967 | TOPIRAMATE | TOPIRAMATE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-596 | Topiramate | Topiramate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-596 | Topiramate | Topiramate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-596 | Topiramate | Topiramate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-691 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 55700-691 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 55700-691 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 55700-894 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 55700-894 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 55700-894 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 55700-894 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 55700-894 | Topiramate | Topiramate | Quality Care Products, LLC | ANDA | Current |
| 61919-439 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-439 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-439 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-439 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-439 | TOPIRAMATE | TOPIRAMATE | Direct_Rx | ANDA | Current |
| 61919-817 | TOPIRAMATE | TOPIRAMATE | DIRECT RX | ANDA | Current |
| 61919-817 | TOPIRAMATE | TOPIRAMATE | DIRECT RX | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23940 | ORIG | 2009-04-14 |