Application 076343
- Type
- ANDA
- Sponsor
- CIPLA LTD
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 |
|---|---|---|---|---|---|---|---|
| A076343-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A076343-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A076343-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A076343-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076343-001 | AB |
| A076343-002 | AB |
| A076343-003 | AB |
| A076343-004 | 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 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-004 | 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 | A076343-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076343-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076343-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076343-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076343-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076343-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076343-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076343-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076343-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076343-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076343-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076343-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076343-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076343-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076343-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076343-004 | 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 | REMEDYREPACK INC. | c90d81a9-a87b-48b0-8cf1-172b82e30127 | 2026-07-31 | Warnings, Adverse reactions | 076343 ANDA076343 70518-2517 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 44095c2b-2e90-45d2-ab45-d0961c41550d | 2026-07-20 | Warnings, Adverse reactions | 076343 ANDA076343 70518-1196 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | b71c09c5-43dd-4d98-9ab6-0b0c99908cac | 2026-07-09 | Warnings, Adverse reactions | 076343 ANDA076343 70518-2391 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | f8aaf403-0e15-4bbb-b88b-253d93439688 | 2026-07-09 | Warnings, Adverse reactions | 076343 ANDA076343 70518-2419 |
| Topiramate | TOPIRAMATE | Coupler LLC | 55f2aca4-b961-a746-e063-6294a90ae8ce | 2026-07-06 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0cf388dc-d8f1-4478-bf5f-e64638ee5801 | 2026-06-29 | Warnings, Adverse reactions | 076343 ANDA076343 70518-0625 |
| Topiramate | TOPIRAMATE | C | 164cb1f7-1a41-675f-e063-6294a90ae0dd | 2026-03-05 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | 7f1e4475-6326-47a3-a317-b04b74b7c109 | 2026-02-02 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | 55e71f43-1cd5-4efc-9641-fda0a09c30f0 | 2026-02-02 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | Northwind Health Company, LLC | ca45d478-7214-5bc7-e053-2995a90aa601 | 2026-01-01 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 1f327383-beb3-4d15-add6-5f1c749f2b3f | 2025-11-18 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | NuCare Pharmaceuticals, Inc. | 490f109f-30cb-0790-e054-00144ff88e88 | 2025-07-24 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 9e516204-8f39-43c9-9f7e-d9777586f321 | 2025-07-15 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | e39d2549-b489-426d-b576-741537e112e7 | 2025-07-15 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | f16b14a2-297f-4adb-8d7a-5f43785faef7 | 2025-06-09 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | ea0bcab1-cfe1-491c-875e-8c865449557e | 2025-04-29 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | Cipla USA Inc. | ca4ec248-285d-4066-8f89-5ed0c538c4c9 | 2025-04-09 | Warnings, Adverse reactions | 076343 ANDA076343 69097-122 69097-123 69097-125 69097-124 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | d63b64dd-b420-4283-9bac-92ba43c9f429 | 2025-01-01 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | eca774cf-2e4e-7642-e053-2a95a90a847d | 2024-12-31 | Warnings, Adverse reactions | 076343 ANDA076343 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | d8dff98f-185e-77ba-e053-2995a90aed2f | 2024-12-31 | Warnings, Adverse reactions | 076343 ANDA076343 |
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 |
|---|---|---|---|---|---|
| 68071-3088 | Topiramate | Topiramate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3088 | Topiramate | Topiramate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3196 | Topiramate | Topiramate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3196 | Topiramate | Topiramate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-5125 | Topiramate | Topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5125 | Topiramate | Topiramate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6916 | Topiramate | Topiramate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7010 | Topiramate | Topiramate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7016 | Topiramate | Topiramate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7016 | Topiramate | Topiramate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69097-122 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-122 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-122 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-122 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-122 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-122 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-122 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-123 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-123 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-123 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-123 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-123 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-123 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-123 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-124 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-124 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-124 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-124 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-124 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-124 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-124 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-125 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-125 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-125 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-125 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-125 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-125 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 69097-125 | Topiramate | Topiramate | Cipla USA Inc. | ANDA | Current |
| 70518-0333 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0333 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0344 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0344 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0370 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0420 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0420 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0625 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0625 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0625 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0625 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0625 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0625 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0625 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1196 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1196 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1196 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1196 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1196 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1196 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-1196 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2391 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2391 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2391 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2391 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2391 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2419 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2419 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2419 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2419 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2517 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2517 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2517 | Topiramate | Topiramate | REMEDYREPACK INC. | ANDA | Current |
| 70934-133 | Topiramate | Topiramate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-133 | Topiramate | Topiramate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-133 | Topiramate | Topiramate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-149 | Topiramate | Topiramate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-149 | Topiramate | Topiramate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-420 | Topiramate | Topiramate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-420 | Topiramate | Topiramate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-450 | Topiramate | Topiramate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-450 | Topiramate | Topiramate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44308 | ORIG | 2009-04-14 |