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Details for Generic Name: clonidine hydrochloride

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Clonidine hydrochloride is the generic ingredient in five branded drugs marketed by Exela Pharma Scs Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Zydus Pharms Usa Inc, Mylan Institutional, Anchen Pharms, Concordia Pharms Inc, Boehringer Ingelheim, Actavis Elizabeth, Alembic Pharms Ltd, Am Therap, Carlsbad, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs, Interpharm, Mutual Pharm, Mylan, Par Pharm, Sandoz, Sun Pharm Inds Inc, Teva, Unichem, Vintage, Warner Chilcott, and Watson Labs, and is included in fifty-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for clonidine hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: clonidine hydrochloride

Drug Master File Entries: see list21
Suppliers: see list4
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: clonidine hydrochloride

Clinical Trials for: clonidine hydrochloride

Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
Status: Completed Condition: Hypertension

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Status: Completed Condition: Hyperemesis Gravidarum

Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
Status: Completed Condition: Healthy

Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
Status: Not yet recruiting Condition: Encephalopathy, Hypoxic-Ischemic

The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients
Status: Not yet recruiting Condition: Delirium

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
Status: Not yet recruiting Condition: Labor Pain

Epidural Clonidine for Lumbosacral Radiculopathy
Status: Terminated Condition: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia
Status: Withdrawn Condition: Full Term Pregnant Patients; Undergoing Lower Segment Caesarian Section

Clonidine Versus Adenosine to Treat Neuropathic Pain
Status: Completed Condition: Pain

The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
Status: Completed Condition: Fascicular Block; Motor Activity; Pain, Postoperative; Latency Period

Comparison of Keppra and Clonidine in the Treatment of Tics
Status: Completed Condition: Tic Disorders; Tourette Syndrome

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
Status: Recruiting Condition: Cannabis Dependence; Marijuana Dependence

Phase I Clinical Trial to Determine the Safety of Clonidine in Infants With HIE During Therapeutic Hypothermia.
Status: Recruiting Condition: Hypoxic Ischemic Encephalopathy (HIE)

Efficacy of Clonidine and Propranolol in Dentistry (AAA)
Status: Recruiting Condition: Anxiety

Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
Status: Terminated Condition: Neonatal Abstinence Syndrome

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
Status: Recruiting Condition: Hot Flashes; Breast Cancer

Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor
Status: Withdrawn Condition: Labor Pain

Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine
Status: Completed Condition: Analgesia; Pain; Systemic Inflammatory Stress Response

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
Status: Completed Condition: Fecal Incontinence

Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery
Status: Recruiting Condition: Pain

Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)
Status: Completed Condition: Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders

A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
Status: Recruiting Condition: Upper Extremity Fracture

Use of Transdermal Clonidine in Trauma Patients
Status: Recruiting Condition: Delirium

Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers
Status: Completed Condition: Acute Pain; Respiration; Sedation

Clonidine Versus Midazolam for Premedication
Status: Completed Condition: Anxiety; Pain

PeriOperative ISchemic Evaluation-2 Trial
Status: Active, not recruiting Condition: Cardiovascular Disease

The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Status: Recruiting Condition: Hernia, Inguinal; Hydrocele

Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain
Status: Completed Condition: Pain

Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure
Status: Completed Condition: Preeclampsia

Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery
Status: Not yet recruiting Condition: Shoulder Arthroscopy; Knee Arthroscopy

Assessment of the Effect of Clonidine for Cataract Surgery
Status: Recruiting Condition: Pain; Arrythmia

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
Status: Recruiting Condition: Spinal Anesthesia; Neonates

Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine
Status: Recruiting Condition: Post-operative Pain

PeriOperative ISchemic Evaluation-2 Pilot
Status: Completed Condition: Cardiovascular Disease

Clonidine and Morphine in Caudal Anesthesia
Status: Completed Condition: Postoperative Pain

A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy
Status: Terminated Condition: Hypertension

Systematic Clonidine for Epidural Analgesia in Labour
Status: Completed Condition: Labour

Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
Status: Completed Condition: Neonatal Abstinence Syndrome

Great Auricular Nerve Block for Tympanomastoid Surgery: Will the Addition of Clonidine Enhance the Duration of Analgesia?
Status: Completed Condition: Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma

Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
Status: Completed Condition: Is an Only Child

Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Adjunctive Clonidine in the Sedation of Mechanically Ventilated Children
Status: Completed Condition: Respiration, Artificial; Critical Illness; Conscious Sedation; Deep Sedation

The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass
Status: Completed Condition: Glycemia During Coronary Artery Bypass Graft; Sedation During Pre-anesthetic Medication

Labor Analgesia With Ropivacaine and Clonidine
Status: Completed Condition: Labor Pain

Clonidine in Femoral Nerve Block Surgery in Children
Status: Not yet recruiting Condition: Other Reconstructive Surgery

Using Clonidine to Improve Leg Weakness in People With Heart Failure
Status: Completed Condition: Heart Failure

Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients
Status: Completed Condition: Opioid-Related Disorders

The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children
Status: Active, not recruiting Condition: Pain; Anxiety

Comparison of Postoperative Analgesic Effect of Intrathecal Clonidine and Fentanyl Added to Bupivacaine in Patients Undergoing Cesarean Section
Status: Completed Condition: Post Operative Pain

Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
Status: Completed Condition: Attention Deficit Disorder With Hyperactivity

EPIC (Evaluating Perioperative Ischemia Reduction by Clonidine)
Status: Active, not recruiting Condition: Heart Disease

Clonidine for Neonatal Abstinence Syndrome Study
Status: Terminated Condition: Neonatal Abstinence Syndrome

Safety and Efficacy Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
Status: Active, not recruiting Condition: Painful Diabetic Neuropathy; Diabetic Neuropathy; Neuropathy

Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery
Status: Completed Condition: Anesthesia

Epidural Clonidine Versus Corticosteroid for Low Back Pain
Status: Recruiting Condition: Back Pain

Clonidine for Neurocognitive Sequelae
Status: Withdrawn Condition: Treatment-Related Cancer

The Oslo Study of Clonidine in Elderly Patients With Delirium
Status: Recruiting Condition: Delirium

Epidural Clonidine for Postoperative Hyperalgesia
Status: Withdrawn Condition: Postoperative Hyperalgesia

Open-Label, Chronic Exposure, Safety Study of CLONICEL (Clonidine HCl Sustained Release) in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Status: Completed Condition: Attention Deficit Hyperactivity Disorder

Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
Status: Recruiting Condition: Oral Mucositis

Pediatric Tonsillectomy Pain Reduction Study
Status: Completed Condition: Postoperative Pain

The Value of Adding Either Meperdine or Fentanyl to Clonidine-bupivacaine
Status: Recruiting Condition: Amputation Stumps

Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial
Status: Completed Condition: Normal Pregnancy

Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Status: Terminated Condition: Ventricular Tachycardia

To Compare lidocaine2%/Clonidine in Combination, With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade
Status: Completed Condition: Bimalleolar Fractures of the Ankle.; Sciatic Nerve Block.; Saphenous Nerve Block.; Post Operative Analgesia Duration.

CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
Status: Completed Condition: ADHD

Clonidine - Ropivacaine in Peribulbar Anesthesia
Status: Completed Condition: Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia

Pilot Study for the NorCAPITAL Trial
Status: Completed Condition: Chronic Fatigue Syndrome

Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Status: Completed Condition: Attention Deficit Disorder With Hyperactivity

Transversus Abdominis Plane (TAP) Block for Cesarean Section
Status: Terminated Condition: Hyperalgesia, Secondary

Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
Status: Completed Condition: Pediatric Spinal Anesthesia

Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?
Status: Completed Condition: Schizophrenia

Effect of Clonidine on Responses to Imagery Scripts
Status: Completed Condition: Cocaine Abuse; Heroin Abuse

Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study
Status: Not yet recruiting Condition: Mechanical Ventilation Complication

Diabetic Neuropathy Topical Treatment
Status: Not yet recruiting Condition: Diabetic Neuropathy; Pain

The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients
Status: Completed Condition: Ascitic Cirrhosis; Hyperactivation of Sympathetic Nervous System

Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
Status: Completed Condition: Pain; Postoperative

Atopic Dermatitis Itch
Status: Not yet recruiting Condition: Cutaneous Nerves CNS Itch

Effects of Intravenous Clonidine on Ocular Blood Flow and Intraocular Pressure
Status: Completed Condition: Physiology

A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
Status: Completed Condition: Sialorrhoea

NAS Treatment - Opiate Versus Non-Opiate
Status: Active, not recruiting Condition: Neonatal Abstinence Syndrome

Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream
Status: Not yet recruiting Condition: - Patients to Benefit a Planned Femoropopliteal Bypass Through PAOD (Peripheral Arterial Occlusive Disease) Stage II or III.

Status of Growth Hormone/ Insulin-like Growth Factor-1 (GH/IGF-1) Axis and Growth Failure in Ataxia Telangiectasia (AT)
Status: Recruiting Condition: Ataxia Telangiectasia; Growth Failure

The Relationships Between the Noradrenergic, Opioid and Pain System
Status: Not yet recruiting Condition: Experimental Pain Perception

Treatment of Orthostatic Intolerance
Status: Recruiting Condition: Tachycardia; Chronic Orthostatic Intolerance

The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial
Status: Completed Condition: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Assessment of Mechanisms of Improved Wound Healing
Status: Completed Condition: Burns

Mechanism and Treatment of Sympathetically Maintained Pain
Status: Recruiting Condition: Complex Regional Pain Syndrome (CRPS)

Study of Clonidine on Sleep Architecture in Children With Tourette's Syndrome (TS) and Comorbid ADHD
Status: Recruiting Condition: Tourette's Syndrome; Attention Deficit Hyperactivity Disorder

Resistant Hypertension Optimal Treatment
Status: Recruiting Condition: Hypertension

DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury
Status: Recruiting Condition: Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Traumatic Brain Injury

Comparison of Low-Dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
Status: Terminated Condition: Pain

Treatment Resistant Depression (Pilot)
Status: Recruiting Condition: Treatment Refractory Depression

Upregulation of Alpha-1 Receptors Upon Septic Shock?
Status: Recruiting Condition: Septic Shock

Treatment of Supine Hypertension in Autonomic Failure
Status: Recruiting Condition: Hypertension

Clonidine and Left Ventricular Dysfunction
Status: Withdrawn Condition: Ventricular Dysfunction

Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty
Status: Enrolling by invitation Condition: Total Knee Arthroplasty; Pain; Nerve Blocks

Vascular Dysfunction in Human Obesity Hypertension
Status: Recruiting Condition: Obesity; Prehypertension; Hypertension

Effects of Topical Clonidine vs. Brimonidine on Choroidal Blood Flow and Intraocular Pressure During Isometric Exercise
Status: Completed Condition: Ocular Physiology; Regional Blood Flow

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dava Pharms Inc
clonidine hydrochloride
TABLET;ORAL071785Apr 5, 1988RXNo<disabled><disabled>
Concordia Pharms Inc
clonidine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022331Sep 28, 2010RXYes5,869,100<disabled>Y<disabled>
Mutual Pharm
clonidine hydrochloride
TABLET;ORAL070925Sep 4, 1987RXNo<disabled><disabled>
Warner Chilcott
clonidine hydrochloride
TABLET;ORAL072139Jun 13, 1988DISCNNo<disabled><disabled>
Warner Chilcott
clonidine hydrochloride
TABLET;ORAL072138Jun 13, 1988DISCNNo<disabled><disabled>
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