Application 201635
- Type
- NDA
- Sponsor
- SUPERNUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | Yes | No |
| 002 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | Yes | No |
| 003 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | Yes | No |
| 004 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-101 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-102 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-103 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
| 17772-104 | Trokendi XR | topiramate | Supernus Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85337 | SUPPL | 2026-03-12 |
| 85300 | SUPPL | 2026-03-09 |
| 85353 | SUPPL | 2026-03-06 |
| 82130 | SUPPL | 2025-05-01 |
| 82129 | SUPPL | 2025-05-01 |
| 81538 | SUPPL | 2025-03-12 |
| 81534 | SUPPL | 2025-03-11 |
| 77201 | SUPPL | 2024-01-10 |
| 77190 | SUPPL | 2024-01-05 |
| 72307 | SUPPL | 2022-10-11 |
| 72306 | SUPPL | 2022-10-11 |
| 72284 | SUPPL | 2022-10-11 |
| 70100 | SUPPL | 2022-02-07 |
| 70099 | SUPPL | 2022-02-07 |
| 70073 | SUPPL | 2022-02-04 |
| 65294 | SUPPL | 2020-11-19 |
| 65279 | SUPPL | 2020-11-19 |
| 65278 | SUPPL | 2020-11-19 |
| 57792 | SUPPL | 2019-02-22 |
| 57774 | SUPPL | 2019-02-22 |
| 50973 | SUPPL | 2018-01-09 |
| 50972 | SUPPL | 2018-01-04 |
| 47955 | SUPPL | 2017-04-12 |
| 47903 | SUPPL | 2017-04-07 |
| 47902 | SUPPL | 2017-04-07 |
| 47901 | SUPPL | 2017-04-07 |
| 45099 | SUPPL | 2016-08-22 |
| 45227 | SUPPL | 2016-08-18 |
| 45141 | SUPPL | 2016-08-18 |
| 40076 | SUPPL | 2015-06-05 |
| 32125 | SUPPL | 2015-05-13 |
| 43369 | ORIG | 2014-06-24 |
| 24397 | ORIG | 2014-06-24 |
| 19027 | ORIG | 2013-08-21 |
| 9914 | ORIG | 2013-08-20 |
| 32124 | ORIG | 2013-06-11 |
| 32123 | ORIG | 2012-06-26 |