vonoprazan tablets; amoxicillin capsules
co-packaged for oral use Initial U.S. Approval: 2022
As specified in the prescribing information, Voquezna Triple Pak is indicated for the treatment of H. pylori infection. 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
Facts about vonoprazan tablets
Approval Date: 5/3/2022
Proprietary Name: Voquezna Triple Pak
Active Ingredient(s): vonoprazan, amoxicillin, clarithromycin
FDA-approved use: To treat H. pylori infection
Dosage Form & Strengths: Co-packaged Tablet and Capsules
- VOQUEZNA TRIPLE PAK : Carton of 14 daily administration packs for morning and evening dosing, each containing the following three drug products (3.1): • Tablets: Vonoprazan 20 mg • Tablets: Clarithromycin 500 mg • Capsules: Amoxicillin 500 mg
- VOQUEZNA DUAL PAK : Carton of 14 daily administration packs for morning, mid-day and evening dosing, each containing the following two drug products (3.2): • Tablets: Vonoprazan 20 mg • Capsules: Amoxicillin 500 mg
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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