Treats Helicobacter pylori (H. pylori) infection. NDA 215153, held by Phathom. Amoxicillin; Vonoprazan Fumarate.
As of Nov 13, 2026, NDA 215153 (Voquezna Dual Pak), held by Phathom, was first approved by FDA on May 3, 2022, with 5 approved supplements and 0 published complete response letters.
VOQUEZNA TRIPLE PAK, is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin class antibacterial, and clarithromycin, a macrolide antimicrobial, indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. VOQUEZNA DUAL PAK, is a co-packaged product containing vonoprazan, a PCAB, and amoxicillin, a penicillin class antibacterial, indicated for the treatment of H. pylori infection in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 2022 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Voquezna Dual Pak500MG;EQ 20MG BASE · capsule, tablet;oral | Amoxicillin; Vonoprazan Fumarate | RxReference drug |
| Oct 31, 2025 | Supplement 12Labeling · Standard review | Approved | |
| Jun 12, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Jul 31, 2024 | Supplement 3Labeling · Standard review | Approved | |
| May 1, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Aug 16, 2023 | Supplement 4Labeling · Standard review | Approved | |
| May 3, 2022 | Original applicationNew formulation or manufacturer · Priority review | Approved |
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
