Application 020505
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOPAMAX | TOPIRAMATE | TABLET;ORAL | 100MG | Yes | Yes |
| 002 | TOPAMAX | TOPIRAMATE | TABLET;ORAL | 200MG | Yes | No |
| 003 | TOPAMAX | TOPIRAMATE | TABLET;ORAL | 300MG | No | No |
| 004 | TOPAMAX | TOPIRAMATE | TABLET;ORAL | 25MG | Yes | No |
| 005 | TOPAMAX | TOPIRAMATE | TABLET;ORAL | 50MG | Yes | No |
| 006 | TOPAMAX | TOPIRAMATE | TABLET;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020505-001 | TOPAMAX | TOPIRAMATE | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 |
| N020505-002 | TOPAMAX | TOPIRAMATE | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 |
| N020505-003 | TOPAMAX | TOPIRAMATE | 300MG | TABLET / ORAL | 1996-12-24 | ||
| N020505-004 | TOPAMAX | TOPIRAMATE | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 |
| N020505-005 | TOPAMAX | TOPIRAMATE | 50MG | TABLET / ORAL | AB | RLD | 1996-12-24 |
| N020505-006 | TOPAMAX | TOPIRAMATE | 400MG | TABLET / ORAL | 1996-12-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020505-001 | AB |
| N020505-002 | AB |
| N020505-004 | AB |
| N020505-005 | 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 | N020505-001 | TOPAMAX | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020505-002 | TOPAMAX | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020505-003 | TOPAMAX | 300MG | TABLET / ORAL | 1996-12-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020505-004 | TOPAMAX | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020505-005 | TOPAMAX | 50MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020505-006 | TOPAMAX | 400MG | TABLET / ORAL | 1996-12-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020505-001 | TOPAMAX | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020505-002 | TOPAMAX | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020505-003 | TOPAMAX | 300MG | TABLET / ORAL | 1996-12-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020505-004 | TOPAMAX | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020505-005 | TOPAMAX | 50MG | TABLET / ORAL | AB | RLD | 1996-12-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020505-006 | TOPAMAX | 400MG | TABLET / ORAL | 1996-12-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020505-001 | TOPAMAX | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020505-002 | TOPAMAX | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020505-003 | TOPAMAX | 300MG | TABLET / ORAL | 1996-12-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020505-004 | TOPAMAX | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020505-005 | TOPAMAX | 50MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020505-006 | TOPAMAX | 400MG | TABLET / ORAL | 1996-12-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020505-001 | TOPAMAX | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020505-002 | TOPAMAX | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020505-003 | TOPAMAX | 300MG | TABLET / ORAL | 1996-12-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020505-004 | TOPAMAX | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020505-005 | TOPAMAX | 50MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020505-006 | TOPAMAX | 400MG | TABLET / ORAL | 1996-12-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020505-001 | TOPAMAX | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020505-002 | TOPAMAX | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020505-003 | TOPAMAX | 300MG | TABLET / ORAL | 1996-12-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020505-004 | TOPAMAX | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020505-005 | TOPAMAX | 50MG | TABLET / ORAL | AB | RLD | 1996-12-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020505-006 | TOPAMAX | 400MG | TABLET / ORAL | 1996-12-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020505-001 | TOPAMAX | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020505-002 | TOPAMAX | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020505-003 | TOPAMAX | 300MG | TABLET / ORAL | 1996-12-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020505-004 | TOPAMAX | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020505-005 | TOPAMAX | 50MG | TABLET / ORAL | AB | RLD | 1996-12-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020505-006 | TOPAMAX | 400MG | TABLET / ORAL | 1996-12-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020505-001 | TOPAMAX | 100MG | TABLET / ORAL | AB | RLD, RS | 1996-12-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020505-002 | TOPAMAX | 200MG | TABLET / ORAL | AB | RLD | 1996-12-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020505-003 | TOPAMAX | 300MG | TABLET / ORAL | 1996-12-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020505-004 | TOPAMAX | 25MG | TABLET / ORAL | AB | RLD | 1996-12-24 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | N020505-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020505-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020505-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020505-005 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020505-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020505-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020505-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020505-005 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020505-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020505-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020505-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020505-005 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020505-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020505-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020505-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020505-005 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020505-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020505-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020505-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020505-005 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020505-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020505-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020505-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020505-005 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020505-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020505-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020505-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020505-005 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020505-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020505-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020505-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020505-005 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020505-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020505-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020505-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020505-005 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020505-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020505-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020505-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020505-005 | AB | 1 | 6a51e52b5d6a… |
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. | 3f99b26b-79b9-4efb-aa2c-2868e1e126c8 | 2026-09-04 | Warnings, Adverse reactions | TOPIRAMATE |
| QUDEXY XR | TOPIRAMATE | Upsher-Smith Laboratories, LLC | 46f54677-3a22-4c38-9b92-923020164e15 | 2026-09-03 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0c0a6774-e234-47a5-866e-462cfd99744c | 2026-09-01 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | Coupler LLC | 59f39dea-f29b-d6c6-e063-6294a90a5b74 | 2026-08-26 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | Coupler LLC | 5826cb22-3559-171b-e063-6394a90ad594 | 2026-08-03 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | c90d81a9-a87b-48b0-8cf1-172b82e30127 | 2026-07-31 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 4833f2e8-16b7-406f-937a-55bc978bf92c | 2026-07-29 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 44095c2b-2e90-45d2-ab45-d0961c41550d | 2026-07-20 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 7e0834ee-920b-496f-954d-f9d81c3ba2d6 | 2026-07-17 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | b71c09c5-43dd-4d98-9ab6-0b0c99908cac | 2026-07-09 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | f8aaf403-0e15-4bbb-b88b-253d93439688 | 2026-07-09 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | Unit Dose Solutions, Inc. | 562f3fec-489b-4662-e063-6294a90a4ea2 | 2026-07-09 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0366164b-1846-443d-9564-dbe52d8d9b65 | 2026-07-08 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | e846124d-e9e6-42c7-83f1-5df170d3f70b | 2026-07-07 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | Coupler LLC | 55f2aca4-b961-a746-e063-6294a90ae8ce | 2026-07-06 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0cf388dc-d8f1-4478-bf5f-e64638ee5801 | 2026-06-29 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 92637f92-9d7c-c246-e053-2995a90a0347 | 2026-06-26 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 9221403c-467f-738e-e053-2995a90ac8fd | 2026-06-26 | Warnings, Adverse reactions | TOPIRAMATE |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 47ef2964-3a41-4bfd-86fb-d44560b9961f | 2026-06-24 | Warnings, Adverse reactions | TOPIRAMATE |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 8abe45eb-cc75-4625-ae3d-5b2a038c4907 | 2026-06-24 | Warnings, Adverse reactions | TOPIRAMATE |
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 |
|---|---|---|---|---|---|
| 21695-128 | Topamax | topiramate | Rebel Distributors Corp | NDA | Current |
| 21695-129 | Topamax | topiramate | Rebel Distributors Corp | NDA | Current |
| 21695-130 | Topamax | topiramate | Rebel Distributors Corp | NDA | Current |
| 50458-639 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-639 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-639 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-639 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-639 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-639 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-639 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-640 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-640 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-640 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-640 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-640 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-640 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-640 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-641 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-641 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-641 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-641 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-641 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-641 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-641 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-642 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-642 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-642 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-642 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-642 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-642 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-642 | Topamax | topiramate | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 55289-433 | Topamax | topiramate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-433 | Topamax | topiramate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-433 | Topamax | topiramate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-433 | Topamax | topiramate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-433 | Topamax | topiramate | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 70518-1393 | Topamax | topiramate | REMEDYREPACK INC. | NDA | Current |
| 70518-1393 | Topamax | topiramate | REMEDYREPACK INC. | NDA | Current |
| 70518-2165 | Topamax | topiramate | REMEDYREPACK INC. | NDA | Current |
| 70518-2753 | Topamax | topiramate | REMEDYREPACK INC. | NDA | Current |
| 70518-2753 | Topamax | topiramate | REMEDYREPACK INC. | NDA | Current |
| 70518-2753 | Topamax | topiramate | REMEDYREPACK INC. | NDA | Current |
| 70518-2753 | Topamax | topiramate | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85350 | SUPPL | 2026-03-12 |
| 85326 | SUPPL | 2026-03-12 |
| 85294 | SUPPL | 2026-03-09 |
| 81587 | SUPPL | 2025-03-17 |
| 81556 | SUPPL | 2025-03-14 |
| 74174 | SUPPL | 2023-05-04 |
| 74167 | SUPPL | 2023-05-04 |
| 72461 | SUPPL | 2022-10-24 |
| 72439 | SUPPL | 2022-10-21 |
| 69913 | SUPPL | 2022-01-19 |
| 69912 | SUPPL | 2022-01-19 |
| 69901 | SUPPL | 2022-01-19 |
| 68018 | SUPPL | 2021-07-07 |
| 68002 | SUPPL | 2021-07-01 |
| 67999 | SUPPL | 2021-07-01 |
| 63470 | SUPPL | 2020-06-09 |
| 63469 | SUPPL | 2020-06-09 |
| 63461 | SUPPL | 2020-06-09 |
| 58553 | SUPPL | 2019-05-03 |
| 58541 | SUPPL | 2019-05-03 |
| 58540 | SUPPL | 2019-05-03 |
| 57103 | SUPPL | 2019-01-02 |
| 57057 | SUPPL | 2018-12-30 |
| 57044 | SUPPL | 2018-12-28 |
| 54689 | SUPPL | 2018-06-26 |
| 54647 | SUPPL | 2018-06-21 |
| 48409 | SUPPL | 2017-05-17 |
| 48381 | SUPPL | 2017-05-16 |
| 12654 | SUPPL | 2014-12-19 |
| 2626 | SUPPL | 2014-12-19 |
| 34736 | SUPPL | 2014-10-23 |
| 2625 | SUPPL | 2014-10-23 |
| 25072 | SUPPL | 2014-04-02 |
| 34735 | SUPPL | 2014-04-01 |
| 12653 | SUPPL | 2014-01-31 |
| 25073 | SUPPL | 2014-01-30 |
| 2624 | SUPPL | 2012-11-01 |
| 34734 | SUPPL | 2012-10-29 |
| 20687 | SUPPL | 2012-02-28 |
| 2623 | SUPPL | 2011-07-19 |
| 12651 | SUPPL | 2011-07-18 |
| 25071 | SUPPL | 2011-03-08 |
| 25070 | SUPPL | 2011-03-08 |
| 12652 | SUPPL | 2011-03-04 |
| 12650 | SUPPL | 2011-03-04 |
| 34732 | SUPPL | 2010-01-04 |
| 34730 | SUPPL | 2010-01-04 |
| 34726 | SUPPL | 2010-01-04 |
| 12648 | SUPPL | 2010-01-04 |
| 25068 | SUPPL | 2009-12-30 |
| 25067 | SUPPL | 2009-12-30 |
| 2621 | SUPPL | 2009-12-30 |
| 2613 | SUPPL | 2009-12-30 |
| 34733 | SUPPL | 2009-05-12 |
| 12649 | SUPPL | 2009-05-12 |
| 25069 | SUPPL | 2009-05-04 |
| 2622 | SUPPL | 2009-05-04 |
| 34731 | SUPPL | 2009-04-28 |
| 25066 | SUPPL | 2006-10-23 |
| 25065 | SUPPL | 2005-07-08 |
| 25064 | SUPPL | 2005-07-08 |
| 34729 | SUPPL | 2005-07-05 |
| 34727 | SUPPL | 2005-07-05 |
| 20686 | ORIG | 2004-09-10 |
| 41401 | SUPPL | 2004-09-08 |
| 12647 | SUPPL | 2004-08-12 |
| 12646 | SUPPL | 2004-08-12 |
| 2620 | SUPPL | 2004-08-12 |
| 2618 | SUPPL | 2004-08-12 |
| 2612 | SUPPL | 2004-06-28 |
| 34728 | SUPPL | 2003-12-29 |
| 34725 | SUPPL | 2003-12-29 |
| 12645 | SUPPL | 2003-12-29 |
| 2615 | SUPPL | 2003-12-19 |
| 2614 | SUPPL | 2003-12-19 |
| 2616 | SUPPL | 2003-06-22 |
| 25062 | SUPPL | 2003-06-08 |
| 2619 | SUPPL | 2003-05-29 |
| 2617 | SUPPL | 2003-05-29 |
| 25063 | SUPPL | 2002-12-09 |
| 34723 | SUPPL | 2001-08-28 |
| 25060 | SUPPL | 2001-08-28 |
| 41402 | SUPPL | 2000-07-03 |
| 41400 | SUPPL | 2000-07-03 |
| 34724 | SUPPL | 1999-10-01 |
| 25061 | SUPPL | 1999-10-01 |
| 34722 | SUPPL | 1999-07-23 |
| 25059 | SUPPL | 1999-07-23 |
| 53030 | SUPPL | 1900-01-01 |
| 53029 | SUPPL | 1900-01-01 |
| 52377 | ORIG | 1900-01-01 |
| 52376 | ORIG | 1900-01-01 |
| 51495 | ORIG | 1900-01-01 |
| 51494 | ORIG | 1900-01-01 |