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Profile for Tradename: AMIODARONE HYDROCHLORIDE

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Amiodarone Hydrochloride is a drug marketed by Akorn, Bedford, Bedford Labs, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Teva Pharms Usa, Wockhardt, Apotex Corp, Barr, Murty Pharms, Mylan, Sandoz, Taro, Teva, Teva Pharms, and Zydus Pharms Usa Inc. and is included in twenty-five NDAs.

The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for Tradename: AMIODARONE HYDROCHLORIDE

Patents:0
Applicants:22
NDAs:25

Clinical Trials for: AMIODARONE HYDROCHLORIDE

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia
Status: Terminated Condition: Defibrillators, Implantable; Tachycardia, Ventricular

Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery
Status: Active, not recruiting Condition: Atrial Fibrillation

Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
Status: Completed Condition: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Status: Completed Condition: Arrhythmia; Atrial Fibrillation; Atrial Flutter

Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation
Status: Completed Condition: Persistent Atrial Fibrillation

Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF
Status: Not yet recruiting Condition: Atrial Fibrillation

Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death
Status: Not yet recruiting Condition: Chagas Cardiomyopathy; Non-sustained Ventricular Tachycardia; At Least 10 Points in Rassi Risk Score for Death

Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation
Status: Completed Condition: Atrial Fibrillation

Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)
Status: Not yet recruiting Condition: Ebola Virus Disease

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft
Status: Completed Condition: Atrial Fibrillation

Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm
Status: Not yet recruiting Condition: Atrial Fibrillation

Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Status: Recruiting Condition: Cardiac Arrest

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)
Status: Withdrawn Condition: Atrial Fibrillation

Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer
Status: Not yet recruiting Condition: Atrial Fibrillation

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
Status: Not yet recruiting Condition: Atrial Fibrillation

Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
Status: Recruiting Condition: Atrial Fibrillation; Lung Cancer

The Effect of Short Term Amiodarone Treatment After Catheter Ablation for Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
Status: Recruiting Condition: Heart Failure

Comparison of Treatment of Atrial Fibrillation (AF) Between Surgical Ultrasonic Technology or Drug Therapy for Patients With AF Requiring Mitral Valve Surgery
Status: Recruiting Condition: Mitral Valvulopathy; Atrial Fibrillation

Pulmonary Vein Ablation Versus Amiodarone in the Elderly
Status: Recruiting Condition: Atrial Fibrillation

A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure
Status: Withdrawn Condition: Blood Pressure

Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Status: Completed Condition: Atrial Fibrillation; Cardiac Surgery

Amiodarone to Prevent Post-Operative Arrhythmias
Status: Completed Condition: Atrial Fibrillation

Bioavailability of Dabigatran and Amiodarone After Multiple Oral Administrations of Dabigatran Etexilate With or Without Amiodarone as Single Dose in Healthy Male and Female Volunteers
Status: Completed Condition: Healthy

Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Status: Completed Condition: Atrial Fibrillation; Atrial Flutter

INTERVENE: Indian Trial of Endocardial Ventricular Substrate Ablation to Prevent Recurrent VT Events
Status: Recruiting Condition: Ventricular Tachycardia

Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation
Status: Recruiting Condition: Atrial Fibrillation

Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
Status: Completed Condition: Persistant Atrial Fibrillation

Prevention of Atrial Fibrillation Following Esophagectomy
Status: Completed Condition: Atrial Fibrillation; Esophagectomy

Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Status: Recruiting Condition: Cardiac Surgery

The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
Status: Completed Condition: Arrhythmia

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death
Status: Completed Condition: Arrhythmia Prophylaxis; Ventricular Arrhythmia

Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm
Status: Completed Condition: Atrial Fibrillation; Cerebrovascular Accident; Death, Sudden

Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Status: Completed Condition: Atrial Fibrillation

Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
Status: Recruiting Condition: Ventricular Tachycardia; Wide QRS Tachycardia

Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study
Status: Not yet recruiting Condition: Atrial Fibrillation; Heart Failure

Atrial Fibrillation and By-pass Surgery
Status: Not yet recruiting Condition: Patients With Coronary Artery Disease Scheduled for by Pass Surgery

Relative Bioavailability of PM101 IV and Cordarone IV
Status: Completed Condition: Healthy

Safety of Amiodarone and Ranolazine Together in Patients With Angina
Status: Recruiting Condition: Chronic Stable Angina; Coronary Artery Disease; Atrial Fibrillation; Ventricular Tachycardia

Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
Status: Completed Condition: Atrial Fibrillation

n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Status: Recruiting Condition: Postoperative Atrial Fibrillation

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)
Status: Completed Condition: Arrhythmia; Cardiovascular Diseases; Heart Arrest; Heart Diseases; Myocardial Infarction; Ventricular Fibrillation

Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia
Status: Recruiting Condition: Ventricular Tachycardia; Coronary Artery Disease

Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

Reduction of Atrial Fibrillation Study in Patients Undergoing Coronary Artery Bypass Grafting. (RASCABG 1 Study)
Status: Completed Condition: Atrial Fibrillation; Coronary Artery Bypass Grafting

Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation (Study MK-4448-006)
Status: Completed Condition: Atrial Fibrillation; Atrial Flutter

In-hospital Cardiac Arrest - Dynamics and State Transitions
Status: Recruiting Condition: Heart Arrest; Death, Sudden, Cardiac

Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)
Status: Active, not recruiting Condition: Atrial Fibrillation; Quality of Life

Ventricular Tachycardia (VT) Ablation Versus Enhanced Drug Therapy
Status: Recruiting Condition: Recurrent Ventricular Tachycardia

Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias
Status: Not yet recruiting Condition: Myocardial Infarction; Ventricular Tachyarrhythmia

Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis
Status: Recruiting Condition: Primary Amyloidosis of Light Chain Type

Anti-arrhythmic Therapy vs Catheter Ablation as First Line Treatment for AICD Shock Prevention
Status: Recruiting Condition: Ventricular Tachycardia; Ventricular Arrhythmia

A Comparison of the Drug Therapy Versus Re-Ablation
Status: Completed Condition: Paroxysmal Atrial Fibrillation; Failed First Radiofrequency Ablation Procedure

Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator
Status: Terminated Condition: Ventricular Tachycardia

High Intensity Focused Ultrasound (HIFU) Ablation System Study
Status: Suspended Condition: Atrial Fibrillation

Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter
Status: Completed Condition: Atrial Fibrillation; Atrial Flutter

Anti-arrhythmic Medication v. MRI-Merge Ablation in the Treatment of Ventricular Tachycardia
Status: Not yet recruiting Condition: Ventricular Tachycardia

A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
Status: Completed Condition: Paroxysmal Atrial Fibrillation

Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
Status: Completed Condition: Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Heart Failure, Congestive; Heart Failure

Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC)
Status: Completed Condition: Ventricular Tachycardia

AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
Status: Terminated Condition: Atrial Fibrillation; Heart Failure

Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
Status: Recruiting Condition: Rheumatic Valve Disease; Atrial Fibrillation

Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Status: Completed Condition: Atrial Fibrillation; Arrhythmia

Antiarrhythmics Versus Implantable Defibrillators (AVID)
Status: Completed Condition: Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Tachycardia, Ventricular; Ventricular Fibrillation

Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome
Status: Completed Condition: Cardiac Arrest

SCD-HeFT 10 Year Follow-up
Status: Active, not recruiting Condition: Left Ventricular Systolic Dysfunction; Congestive Heart Failure; Ischemic and Non-ischemic Cardiomyopathy; Sudden Cardiac Death Primary Prevention

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)
Status: Completed Condition: Arrhythmia; Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases

Reversal of Cardiomyopathy by Suppression of Frequent Premature Ventricular Complexes
Status: Recruiting Condition: Heart Diseases; Cardiac Arrhythmias; Ventricular Premature Complexes; Systolic Heart Failure; Cardiomyopathies

Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks
Status: Not yet recruiting Condition: ICD; ICD SHOCKS; DRONEDARONE

Spanish Atrial Fibrillation And Resynchronization Study
Status: Active, not recruiting Condition: Chronic Heart Failure; Cardiomyopathy, Dilated; Atrial Fibrillation

Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China
Status: Recruiting Condition: Atrial Fibrillation

Therapy of Atrial Flutter by Afib Ablation
Status: Recruiting Condition: Atrial Fibrillation; Atrial Flutter

Catheter Ablation Versus Medical Treatment of AF in Heart Failure
Status: Recruiting Condition: Atrial Fibrillation; Heart Failure

Prevention of Postoperative Atrial Fibrillation
Status: Completed Condition: Postoperative Atrial Fibrillation

Kansai Plus Atrial Fibrillation Trial
Status: Active, not recruiting Condition: Atrial Fibrillation

OPERA: French Observational Study on Patients Implanted With a Guidant PRIZM or Vitality Defibrillator
Status: Completed Condition: Ventricular Tachycardia; Ventricular Fibrillation

Antiarrythmic Drugs - Long-term Follow-up in the Modern Era
Status: Active, not recruiting Condition: Cardiac Dysrhythmia

Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
Status: Completed Condition: Heart Disease; Arrhythmia; Atrial Fibrillation

A Retrospective Analysis of the Use of ACE-inhibitors and Angiotensin Receptor Blockers
Status: Completed Condition: Atrial Fibrillation; Atrial Flutter

Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Status: Completed Condition: Heart Diseases

Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin
Status: Completed Condition: Healthy

GISSI-AF - Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
Status: Completed Condition: Atrial Fibrillation

Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation
Status: Recruiting Condition: Atrial Fibrillation

Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients
Status: Recruiting Condition: Morbid Obesity; Non Alcoholic Steatohepatitis

Randomized Trial Comparing Diltiazem and Metoprolol For Atrial Fibrillation Rate Control
Status: Recruiting Condition: Atrial Fibrillation; Atrial Flutter

Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
Status: Completed Condition: Atrial Fibrillation; Hypertrophic Cardiomyopathy

Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)
Status: Active, not recruiting Condition: Atrial Fibrillation

Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation
Status: Recruiting Condition: Hypertension; Atrial Fibrillation

Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Status: Completed Condition: Atrial Fibrillation

Effectiveness Study of Atrial Fibrillation
Status: Recruiting Condition: Atrial Fibrillation

Comparison of Externally Versus Internally Cooled Tip Catheter Ablation in Paroxysmal Atrial Fibrillation
Status: Terminated Condition: Atrial Fibrillation

Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
Status: Recruiting Condition: Atrial Fibrillation; Arrhythmia

Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA)
Status: Terminated Condition: Atrial Fibrillation

Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
Status: Terminated Condition: Atrial Fibrillation

American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm
Status: Completed Condition: Atrial Fibrillation; Atrial Flutter

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Taro
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET; ORAL075424Mar 30, 2001RXNo<disabled><disabled>
Hospira
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
INJECTABLE; INJECTION075955Oct 18, 2002RXYes<disabled><disabled>
Apotex Corp
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET; ORAL078578Nov 6, 2008RXNo<disabled><disabled>
Sandoz
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET; ORAL075315Jun 30, 2000RXNo<disabled><disabled>
Taro
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride
TABLET; ORAL076362Dec 2, 2003RXNo<disabled><disabled>
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