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Details for Generic Name: diazepam

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Diazepam is the generic ingredient in eight branded drugs marketed by Roche, Lannett Holdings Inc, Roxane, Valeant, Abraxis Pharm, Hikma Maple , Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Pharmacia And Upjohn, Actavis Elizabeth, Barr, Dava Pharms Inc, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Par Pharm, Pioneer Pharms, Sandoz, Teva Pharms, Vintage Pharms, and Quantum Pharmics, and is included in eigthy-three NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for diazepam. Seven suppliers are listed for this compound.

Summary for Generic Name: diazepam

Tradenames:8
Patents:1
Applicants:29
NDAs:83
Drug Master File Entries: see list8
Suppliers: see list7

Pharmacology for Ingredient: diazepam

Ingredient-typeBenzodiazepines
Drug ClassBenzodiazepine

Clinical Trials for: diazepam

Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems
Status: Terminated Condition: Metabolism, Drug

A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Status: Completed Condition: Epilepsy

Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
Status: Active, not recruiting Condition: Posttraumatic Stress Disorder

Exploring the Effects of Diazepam and Lorazepam
Status: Completed Condition: Healthy Subjects

Vaginal Diazepam for the Treatment of Female Pelvic Pain
Status: Recruiting Condition: Pelvic Floor Disorders; Pelvic Pain

A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal
Status: Completed Condition: Alcohol Withdrawal

Diazepam at the Active Phase of Labor
Status: Not yet recruiting Condition: Pain; Prolonged Labour

Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse
Status: Recruiting Condition: Alcoholism

Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
Status: Completed Condition: Seizures

Freedom SOLO Stentless Heart Valve Study
Status: Active, not recruiting Condition: Aortic Stenosis; Aortic Insufficiency

Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
Status: Completed Condition: Status Epilepticus

Lofexidine for Inpatient Opiate Detox in Singapore
Status: Recruiting Condition: Opiate Dependent Patients Who Are Undergoing Inpatient Detoxification in Singapore

Comparative Study of Hemodynamic Changes Caused by Diazepam and Midazolam During Third Molar Surgery
Status: Completed Condition: Anxiety

Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Status: Active, not recruiting Condition: Heart Valve Diseases

An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray in Adolescents and Adults With Cluster Seizures
Status: Recruiting Condition: Epilepsy

Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
Status: Completed Condition: Female Patients With High Tone Pelvic Floor Dysfunction

Feasibility Study of the Solo™ Insulin Pump
Status: Completed Condition: Type 1 Diabetes; Insulin Pump Users

A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
Status: Completed Condition: Epilepsy

Performance Study of the SOLO 2.0 Insulin Pump
Status: Recruiting Condition: Type 1 Diabetes

Comparison Between Nurse-Administered Propofol Sedation and Diazemuls / Pethidine in Outpatient Colonoscopy
Status: Completed Condition: Colonoscopy

A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System
Status: Enrolling by invitation Condition: Home Healthcare Organizations Utilizing Ambulatory Infusion Pumps; Patients Requiring Infusion With an Ambulatory Infusion Pump

Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT
Status: Recruiting Condition: Healthy

Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Status: Terminated Condition: Breast Cancer

Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
Status: Completed Condition: Status Epilepticus

Efficacy and Safety of Vanquix for the Management of Selected, Refractory, Patients With Epilepsy Who Require Intermittent Caregiver Medical Intervention to Control Episodes of Acute Repetitive Seizures.
Status: Completed Condition: Seizures; Epilepsies, Partial; Epilepsy, Complex Partial; Epilepsy, Generalized; Epilepsy

Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
Status: Completed Condition: Pancreatic Neoplasms

Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain
Status: Completed Condition: Cannabinoid; Tetrahydrocannabinol; Chronic Pancreatitis; Abdominal Pain

Model Driven Diabetes Care
Status: Completed Condition: Diabetes Mellitus, Type 1

The PROOF Study: The PICC Related Obstruction Of Flow Study
Status: Terminated Condition: Patients Indicated for a PICC for Any Medical Condition

Perioperative Δ9-THC for Postsurgical Pain
Status: Recruiting Condition: Pain

Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome
Status: Completed Condition: Alcohol Withdrawal Syndrome

Implementing Health Plan-Level Care Management for Solo & Small Practices
Status: Enrolling by invitation Condition: Bipolar Disorder; Depression

The Effect of Prescription Medications in Marijuana Users
Status: Recruiting Condition: Marijuana Abuse

Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
Status: Recruiting Condition: Breast Cancer

Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
Status: Completed Condition: Wound Infection; Abscess; Systemic Inflammation; Cellulitis

Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection
Status: Completed Condition: Wound Infection; Abscess; Systemic Inflammation; Cellulitis

Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System
Status: Completed Condition: Solid Tumors; Cancer

A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
Status: Recruiting Condition: Post-operative Pain

Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer
Status: Recruiting Condition: Early Stage Breast Carcinoma

Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma
Status: Recruiting Condition: Asthma

Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
Status: Active, not recruiting Condition: Benzodiazepine-resistant Alcohol Withdrawal Syndrome

Factors Affecting Medical Student Learning in Simulation Scenarios
Status: Completed Condition: Learning

A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users
Status: Completed Condition: Healthy Volunteer

A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System
Status: Recruiting Condition: Peripheral Artery Disease

Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
Status: Completed Condition: Breast Cancer

An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice (ACT-SOLO)
Status: Active, not recruiting Condition: Rheumatoid Arthritis

Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse
Status: Completed Condition: Pain; Disability; Paresis

Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
Status: Completed Condition: Methamphetamine-induced Psychosis

Quality of Sleep in Patients With Rheumatoid Arthritis
Status: Recruiting Condition: Rheumatoid Arthritis

Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect
Status: Completed Condition: Pain

Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability
Status: Recruiting Condition: Dental Care for Disabled

Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression
Status: Recruiting Condition: Depression

RCT of Mesh Versus Jet Nebulizers on Clinical Outcomes During Mechanical Ventilation in the Intensive Care Unit
Status: Recruiting Condition: Respiratory Insufficiency

SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
Status: Completed Condition: Asthma

Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
Status: Terminated Condition: Obesity; Diabetes Mellitus Type 2

Olaparib Treatment in Relapsed Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments.
Status: Not yet recruiting Condition: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Status: Not yet recruiting Condition: Dermatitis, Atopic

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Status: Not yet recruiting Condition: Dermatitis, Atopic

Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
Status: Completed Condition: Breast Cancer

Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System
Status: Completed Condition: Head and Neck Cancer

Biofeedback for Dyssynergic Constipation
Status: Completed Condition: Constipation

Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome
Status: Completed Condition: Topiramate; Lamotrigine; Memnatine; Diazepam; Placebo

Partner Assistance in Learning and Performing Skin Self-Examination
Status: Completed Condition: Melanoma

Gabapentin Treatment of Benzodiazepine Dependence
Status: Recruiting Condition: Benzodiazepine Dependence

Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
Status: Recruiting Condition: Acute Respiratory Insufficiency; Chronic Respiratory Insufficiency; Bronchospasm and Obstruction

The Vertigo Study: Comparison Between Convention Therapy and Vestibular Rehabilitation for Benign Paroxysmal Positional Vertigo (BPPV) in Emergency Department (ED) Patients
Status: Enrolling by invitation Condition: Benign Paroxysmal Positional Vertigo

YouScript IMPACT Registry
Status: Recruiting Condition: Adverse Drug Events; Adverse Drug Reactions; Drug Interaction Potentiation; Drug Metabolism, Poor, CYP2D6-RELATED; Drug Metabolism, Poor, CYP2C19-RELATED; Cytochrome P450 Enzyme Deficiency; Cytochrome P450 CYP2D6 Enzyme Deficiency; Cytochrome P450 CYP2C9 Enzyme Deficiency; Cytochrome P450 CYP2C19 Enzyme Deficiency; Cytochrome P450 CYP3A Enzyme Deficiency; Poor Metabolizer Due to Cytochrome P450 CYP2C9 Variant; Poor Metabolizer Due to Cytochrome P450 CYP2C19 Variant; Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant

Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures
Status: Recruiting Condition: Febrile Seizure

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

How to Ease the Withdrawal of Tranquilizers Among Older Consumers?
Status: Recruiting Condition: Drug Dependence

Assessment of the Ability of Ionic Foot Bath (IonCleanse®) to Remove Heavy Metals Through the Feet and Its Potential Impact on Body Burden of Heavy Metals
Status: Completed Condition: Healthy

Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
Status: Active, not recruiting Condition: Breast Cancer

The Comparison of Different Administration Routes of Pediatric Premedication
Status: Not yet recruiting Condition: Anesthesia

CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs
Status: Enrolling by invitation Condition: Superficial Femoral Artery Stenosis

Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction
Status: Completed Condition: ST-Elevation Myocardial Infarction

Short-term Endothelin A Receptor Blockade in Patients With On-pump CABG
Status: Enrolling by invitation Condition: Coronary Artery Disease; Aorto-coronary Bypass Grafting

Comparison of PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast
Status: Active, not recruiting Condition: Breast Cancer

CC-486 (Oral Azacitidine) Bioequivalence Study in Patients With Solid Tumor or Hematologic Malignancies
Status: Recruiting Condition: Hematological Neoplasms; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Lymphoma; Multiple Myeloma; Acute Myeloid Leukemia; Leukemia; Myelodysplastic Syndromes; Neoplasms; Melanoma; Breast Cancer; Metastatic Breast Cancer; Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Renal Cell Carcinoma; Glioblastoma Multiforme; Osteosarcoma; Sarcoma; Thyroid Cancer; Genitourinary

Optimal Dose of Propofol for Induction of Deep Sedation for Brain MRI Scanning in Children With Cerebral Palsy
Status: Completed Condition: Cerebral Palsy

Extended-release Epidural Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children
Status: Recruiting Condition: Spastic Cerebral Palsy

Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
Status: Completed Condition: Myopia; Hyperopia

A Controlled Study of Parent Training in the Treatment of ADHD in Young Children
Status: Recruiting Condition: Attention Deficit Hyperactivity Disorder

Electrical Status Epilepticus in Sleep: Response of Neuropsychological Deficits and Epileptiform Activity to Clobazam Treatment
Status: Recruiting Condition: Electrical Status Epilepticus in Sleep

Aminophylline and Cognitive Function After Sevoflurane Anaesthesia
Status: Completed Condition: Anaesthesia

An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
Status: Completed Condition: Fibromyalgia, Primary

Acamprosate to Reduce Symptoms of Alcohol Withdrawal
Status: Completed Condition: Alcohol-Related Disorders; Alcohol Dependence; Alcoholism; Healthy Volunteer

Haemodynamic Effects During Anorectal Surgery: a Comparison of the Jack -Knife and Lithotomy Position
Status: Recruiting Condition: Anorectal Surgery Haemodynamic Changes

Effects of Delta-9-THC and Iomazenil in Healthy Humans
Status: Recruiting Condition: Schizophrenia; Mental Disorders; Psychotic Disorders

Alcohol Detoxification in Primary Care Treatment (ADEPT)
Status: Completed Condition: Alcoholism

Effects of Flumazenil on Brain Excitability
Status: Completed Condition: Stroke; Healthy

Brain Activity During Production of Movement
Status: Completed Condition: Healthy

Botulinum Toxin for Pelvic Pain in Women With Endometriosis
Status: Recruiting Condition: Endometriosis; Botulinum Toxin A; Chronic Pelvic Pain; Pelvic Muscle Spasms; Quality of Life

Method Pilates X Pilates in Water Postural Alignment and Its Correlation With Respiratory Capacity With Hemiparesis Spastic
Status: Recruiting Condition: Stroke

Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction
Status: Completed Condition: Anxiety; Sexual Dysfunction

Dextromethorphan to Treat Patients With Voice Spasms
Status: Completed Condition: Voice Disorders

Clarithromycin for the Treatment of Hypersomnia
Status: Completed Condition: Hypersomnia; Idiopathic Hypersomnia; Narcolepsy

Flumazenil for the Treatment of Primary Hypersomnia
Status: Completed Condition: Hypersomnia; Primary Hypersomnia; Idiopathic Hypersomnia; Narcolepsy Without Cataplexy

The Effect of Bariatric Surgery on Peripheral Nerve Function and Axonal Regeneration
Status: Recruiting Condition: Peripheral Neuropathy; Obesity

Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities
Status: Recruiting Condition: Burns

Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
Status: Completed Condition: Schizophrenia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Maple
DIAZEPAM
diazepam
INJECTABLE;INJECTION071310Jul 17, 1987DISCNNo<disabled><disabled>
Watson Labs
DIAZEPAM
diazepam
INJECTABLE;INJECTION070911Aug 28, 1986DISCNNo<disabled><disabled>
Par Pharm
DIAZEPAM
diazepam
TABLET;ORAL070462Feb 25, 1986DISCNNo<disabled><disabled>
Dava Pharms Inc
DIAZEPAM
diazepam
TABLET;ORAL070228Sep 26, 1985DISCNNo<disabled><disabled>
Quantum Pharmics
Q-PAM
diazepam
TABLET;ORAL072431Apr 29, 1988DISCNNo<disabled><disabled>
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