Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Supernus Pharmaceuticals with 5 drug applications, 3 drug recalls, 2 OPDP letters and 1 complete response letter. The most recent is a drug recall dated Aug 31, 2026: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufa….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 31, 2026 | Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KYClass III · Failed dissolution specifications. | Drug recalls |
| Jul 6, 2026 | Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40Class III · Failed Dissolution Specifications | Drug recalls |
| Sep 9, 2025 | Untitled letter: QelbreeOffice of Prescription Drug Promotion | OPDP letters |
| Sep 9, 2025 | Untitled letter: QelbreeOffice of Prescription Drug Promotion | OPDP letters |
| Nov 6, 2020 | Complete response letter, NDA 211964Approved | Complete response letters |
| Jul 12, 2016 | Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, WinchesClass II · Superpotent Drug: Failure of assay specifications in the capsule. | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
