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 |
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 |