Treats hypertension. Sold as Katerzia. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Amlodipine Benzoate (sold as Katerzia), first approved Jul 8, 2019, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Katerzia | Part D | $1.5M | -3% | 372 |
| Jul 8, 2019 | KaterziaNDA 211340 · New formulation or manufacturer | Azurity | 1 | Marketed |
| Jun 13, 2023 | Amlodipine BenzoateANDA 215035 | Amneal | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
