NDA 214622, held by Helsinn Hlthcare. Infigratinib Phosphate.
As of Nov 13, 2026, NDA 214622 (Truseltiq), held by Helsinn Hlthcare, was first approved by FDA on May 28, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Truseltiq25MG · capsule;oral | Infigratinib Phosphate | DiscontinuedReference drug |
| Truseltiq100MG · capsule;oral | Infigratinib Phosphate | DiscontinuedReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
