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Details for Generic Name: diazepam

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

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

Summary for Generic Name: diazepam

Tradenames:8
Patents:0
Applicants:30
NDAs:81
Drug Master File Entries: see list8
Suppliers / Packaging: see list17

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

A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
Status: Recruiting Condition: Healthy

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

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

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

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

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

A Study to Determine the Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
Status: Recruiting Condition: Refractory Epilepsy

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

A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
Status: Not yet recruiting Condition: Infertility

Diazepam for Acute LBP
Status: Recruiting Condition: Low Back Pain

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

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

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

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

Freedom SOLO Stentless Heart Valve Study
Status: Completed Condition: Aortic Stenosis; Aortic Insufficiency

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

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

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

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

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

Liposomal Bupivacaine in Implant Based Breast Reconstruction
Status: Recruiting Condition: Breast Cancer; Postoperative Pain

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

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

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

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

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

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

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

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

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

Dexmedetomidine Addition to Benzodiazepines for Patients With Alcohol Withdrawal State in the ICU
Status: Completed Condition: Alcohol Withdrawal State

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

Implementing Health Plan-Level Care Management for Solo & Small Practices
Status: Active, not recruiting Condition: Bipolar Disorder; Depression

Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
Status: Completed Condition: Alcohol Withdrawal Syndrome

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

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

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

ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
Status: Recruiting Condition: Osteoarthritis; Post-traumatic Arthritis

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

Association Between Bolus Rate and Duration of Adequate Labor Analgesia
Status: Recruiting Condition: Labor Pain; Obstetric Pain

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

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

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

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

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

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

Tomographic Comparison of Aerosol Lung Distribution With Two Nebulizers Through a High Flow Nasal Cannula
Status: Recruiting Condition: Healthy

A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System
Status: Active, not 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: Completed Condition: Rheumatoid Arthritis

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

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

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

Pharmacovigilance in Gerontopsychiatric Patients
Status: Recruiting Condition: Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders

Biofeedback for Dyssynergic Constipation
Status: Completed Condition: Constipation

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

Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly
Status: Enrolling by invitation Condition: Sleep Disorders

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

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 Germline 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: 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: Active, not recruiting Condition: Dermatitis, Atopic

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

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Status: Active, not recruiting Condition: Newly Diagnosed; Advanced Ovarian Cancer; FIGO Stage III-IV; BRCA Mutation; Complete Response; Partial Response; First Line Platinum Chemotherapy

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

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Status: Recruiting Condition: Infection; Hypertension; Pain; Reflux; Edema; Hyperlipidemia; Hypotension; Hypercholesterolemia; Sedation; Anxiolysis; Benzodiazepine Withdrawal; Bipolar Disorder; Autistic Disorder; Schizophrenia; Influenza Treatment or Prophylaxis; Acute Decompensated Heart Failure; Stable Angina; Life-threatening Fungal Infections; Nosocomial Pneumonia; Community Acquired Pneumonia; Acute Bacterial Exacerbation of Chronic Bronchitis; Complicated Skin and Skin Structure Infections; Uncomplicated Skin and Skin Structure Infections; Chronic Bacterial Prostatitis; Complicated Urinary Tract Infections; Acute Pyelonephritis; Uncomplicated Urinary Tract Infections; Inhalational Anthrax (Post-Exposure); Infantile Hemangioma; Withdrawal; Inflammation; Bacterial Septicemia; Cytomegalovirus Retinitis; Herpes Simplex Virus; Adenovirus; Brain Swelling; Airway Swelling; Adrenal Insufficiency; Anxiety; Nausea; Vomiting; Convulsions; Muscle Spasms; Seizures; Epilepsy; Bartonellosis; Brucellosis; Cholera; Plague; Psittacosis; Q Fever; Relapsing Fever; Rocky Mountain Spotted Fever; Trachoma; Tularemia; Typhus Fever; Bronchospasm; Cardiac Arrest; Hypersensitivity Reaction; Cyanide Poisoning; Acute Bacterial Sinusitis; Bacterial Meningitis; Sepsis; Gastroparesis; Opioid Addiction; Migraines; Headaches

A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)
Status: Enrolling by invitation Condition: Atopic Dermatitis

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

A Study of the ReCor Medical Paradise System in Clinical Hypertension
Status: Not yet recruiting Condition: Hypertension; Vascular Diseases

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

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: Withdrawn Condition: Ebola Virus Disease

YouScript IMPACT Registry
Status: Completed 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

Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
Status: Completed 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

Analysis of Deposition With Nebulizers Membrane
Status: Recruiting Condition: Healthy Volunteers

Aerogen Nebuliser Versus Standard Nebulised Therapy in Acute Chronic Obstructive Pulmonary Disease
Status: Recruiting Condition: COPD

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

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

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

Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor
Status: Recruiting Condition: Labor Pain

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

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

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

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

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

Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints
Status: Recruiting Condition: Minor Procedural Pain

Comparison of PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast
Status: Completed Condition: Breast Cancer

Effects of GABA Modulator AZD7325 on Cutaneous Sensation
Status: Recruiting Condition: Healthy

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quantum Pharmics
Q-PAM
diazepam
TABLET;ORAL070425-001Dec 12, 1985DISCNNo<disabled><disabled>
Halsey
DIAZEPAM
diazepam
TABLET;ORAL070987-001Aug 15, 1986DISCNNo<disabled><disabled>
Quantum Pharmics
Q-PAM
diazepam
TABLET;ORAL072433-001Apr 29, 1988DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: diazepam

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
DIASTAT
diazepam
GEL;RECTAL020648-001Jul 29, 19975,462,740<disabled>
Roche
VALIUM
diazepam
TABLET;ORAL013263-002Approved Prior to Jan 1, 19824,316,897<disabled>
Roche
VALRELEASE
diazepam
CAPSULE, EXTENDED RELEASE;ORAL018179-001Approved Prior to Jan 1, 19824,316,897<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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