NDA 218710, held by Phathom Pharmaceuticals Inc. Vonoprazan Fumarate.
As of Nov 14, 2026, NDA 218710 (Voquezna), held by Phathom Pharmaceuticals Inc, was first approved by FDA on Jul 17, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 17, 2024 | Original applicationNew indication · Standard review | Approved |
| VoqueznaEQ 10MG BASE · tablet; oral | Vonoprazan Fumarate | Rx |
| VoqueznaEQ 20MG BASE · tablet; oral | Vonoprazan Fumarate | Rx |
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
