Tools / Drug approvals and letters / Drugs Amlodipine Besylate Treats hypertension. Sold as Norvasc, Amlodipine Besylate, Norliqva, Sdamlo. Every FDA application for this active ingredient: 4 branded and 40 generic.
As of Nov 15, 2026, FDA lists 44 applications for Amlodipine Besylate (sold as Norvasc, Amlodipine Besylate, Norliqva and others), first approved Jul 31, 1992, with 4 new uses approved and 1 published complete response letter.
First approved : Jul 31, 1992 Applications : 44 New uses approved : 4 Complete response letters : 1 Medicare spending, 2025 : $361M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Amlodipine Besylate Part D $348M +10% 12,622,528 Norvasc Part D $12.7M -12% 4,636 Norliqva Part D $1.0M +58% 324
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change AMLODIPINE BESYLATE 10 MG TAB: $0.014 per unit Generic · -14% in a year AMLODIPINE BESYLATE 2.5 MG TAB: $0.011 per unit Generic · +7% in a year AMLODIPINE BESYLATE 5 MG TAB: $0.010 per unit Generic · -9% in a year NORVASC 10 MG TABLET: $11.92 per unit Brand · +6% in a year NORVASC 2.5 MG TABLET: $8.70 per unit Brand · +5% in a year NORVASC 5 MG TABLET: $8.69 per unit Brand · +5% in a year NORLIQVA 1 MG/ML SOLUTION: $3.21 per ML Brand · -2% in a year FDA Drug Safety Communications One communication since 2020 that name this drug; see all communications Amlodipine Drugs with a new additional pediatric dosages. · Kyowa Pharmaceutical Industry Co., Ltd. · Jun 22, 2012 Amlodipine Drugs with a new additional pediatric dosage. · Towa Pharmaceutical Co., Ltd. · Jun 22, 2012 Norvasc Drugs with a new dosage indicated for the treatment of hypertension and angina pectoris. · Dainippon Sumitomo Pharma Co., Ltd. · Feb 23, 2009 Clinical Trials 61 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential Hypertension Hypertension (HTN), Low-Renin Essential Hypertension · China National Center for Cardiovascular Diseases Phase 4 Not yet recruiting Nov 12, 2026 Blood Pressure Control and Safety of Ex-one or Ex-one Plus in Essential Hypertension Essential Hypertension · HK inno.N Corporation — Recruiting Nov 12, 2026 A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy Hypertension (HTN), Hypertension · Ahn-Gook Pharmaceuticals Co.,Ltd — Not yet recruiting Oct 30, 2026 Comparing Inclisiran Versus Statin for Primary Aldosteronism Primary Aldosteronism · Third Military Medical University Not applicable Recruiting Oct 21, 2026 Ramipril vs. Amlodipine in Pediatric Hemodialysis Patients Endothelial Dysfunction, End-Stage Renal Disease · Ain Shams University Phase 3 Not yet recruiting Oct 19, 2026 Monitoring the Effectiveness and Safety of Antihypertensive Therapy With a Fixed-Dose Combination of Perindopril and Amlodipine in Patients With Uncontrolled Essential Hypertension Essential Hypertension · Bosnalijek D.D — Active, not recruiting Oct 15, 2026 Sitogilun Malate Plus Amlodipine in Patients With Hypertension and Risk of Early Kidney Damage Hypertension · Shanghai Jiao Tong University School of Medicine Phase 4 Recruiting Oct 15, 2026 VITAL: Real-World Evaluation of Amlodipine/Valsartan. Hypertension, Cardiovascular Diseases (CVD) · VIVA PHARM LLP — Active, not recruiting Sep 29, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Jul 31, 1992 Norvasc NDA 19787 · New molecular entity 45 Marketed Oct 3, 2005 Amlodipine Besylate ANDA 76418 4 Discontinued May 23, 2007 Amlodipine Besylate ANDA 76719 5 Marketed Jun 27, 2007 Amlodipine Besylate ANDA 77080 0 Discontinued Jun 28, 2007 Amlodipine Besylate ANDA 76846 10 Marketed Jul 9, 2007 Amlodipine Besylate ANDA 77262 5 Discontinued Jul 9, 2007 Amlodipine Besylate ANDA 77362 0 Discontinued Jul 9, 2007 Amlodipine Besylate ANDA 77759 5 Discontinued Jul 9, 2007 Amlodipine Besylate ANDA 78226 9 Marketed Jul 9, 2007 Amlodipine Besylate ANDA 77974 4 Discontinued Jul 11, 2007 Amlodipine Besylate ANDA 77516 2 Discontinued Jul 12, 2007 Amlodipine Besylate ANDA 78043 5 Marketed Jul 17, 2007 Amlodipine Besylate ANDA 78021 8 Marketed Jul 19, 2007 Amlodipine Besylate ANDA 77671 0 Discontinued Jul 20, 2007 Amlodipine Besylate ANDA 76692 3 Marketed Aug 28, 2007 Amlodipine Besylate ANDA 77955 7 Marketed Sep 4, 2007 Amlodipine Besylate ANDA 78131 0 Discontinued Sep 6, 2007 Amlodipine Besylate ANDA 78500 1 Discontinued Sep 10, 2007 Amlodipine Besylate ANDA 76859 0 Discontinued Sep 26, 2007 Amlodipine Besylate ANDA 77073 5 Marketed Sep 27, 2007 Amlodipine Besylate NDA 22026 · New dosage form 0 Discontinued Nov 30, 2007 Amlodipine Besylate ANDA 78231 1 Discontinued Jan 16, 2008 Amlodipine Besylate ANDA 78477 8 Discontinued Jan 31, 2008 Amlodipine Besylate ANDA 78081 1 Discontinued Feb 27, 2008 Amlodipine Besylate ANDA 78224 0 Discontinued Sep 22, 2008 Amlodipine Besylate ANDA 78573 7 Discontinued Apr 8, 2009 Amlodipine Besylate ANDA 78552 6 Marketed May 4, 2009 Amlodipine Besylate ANDA 78925 6 Marketed Jul 2, 2009 Amlodipine Besylate ANDA 78453 6 Marketed Apr 7, 2010 Amlodipine Besylate ANDA 78414 5 Marketed Apr 12, 2011 Amlodipine Besylate ANDA 77771 4 Discontinued Apr 15, 2011 Amlodipine Besylate ANDA 90752 4 Marketed Apr 13, 2012 Amlodipine Besylate ANDA 201380 6 Marketed Apr 29, 2013 Amlodipine Besylate ANDA 202553 2 Marketed Oct 21, 2013 Amlodipine Besylate ANDA 203245 3 Marketed Jul 23, 2015 Amlodipine Besylate ANDA 204900 0 Discontinued Dec 10, 2015 Amlodipine Besylate ANDA 206367 1 Marketed Jul 11, 2016 Amlodipine Besylate ANDA 207821 2 Marketed May 4, 2018 Amlodipine Besylate ANDA 206524 0 Discontinued Feb 24, 2022 Norliqva NDA 214439 · New formulation or manufacturer 1 Marketed Jul 24, 2025 Sdamlo NDA 219531 · New dosage form 1 Marketed Jan 22, 2026 Amlodipine Besylate ANDA 219686 0 Discontinued Sep 22, 2026 Amlodipine Besylate ANDA 210489 0 Marketed — Amlodipine Besylate ANDA 77333 0 Discontinued
Complete Response Letters FDA's published letters for these applications Letter Product Now Apr 22, 2021 NORLIQVA (amlodipine) Facility Inspections, Additional Product Quality Comment Approved
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
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