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Details for Generic Name: promethazine hydrochloride

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Summary for Generic Name: promethazine hydrochloride

Tradenames:13
Patents:0
Applicants:48
NDAs:87
Drug Master File Entries: see list12
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details

Clinical Trials for: promethazine hydrochloride

Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine
Status: Active, not recruiting Condition: Drug Metabolism, Poor, CYP2D6-RELATED

Diphenhydramine for Acute Migraine
Status: Completed Condition: Migraine

Study of Promethazine for Treatment of Diabetic Gastroparesis
Status: Recruiting Condition: Diabetic Gastroparesis

Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Status: Completed Condition: Cough Reflex Sensitivity

Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
Status: Completed Condition: Healthy

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Status: Completed Condition: Sleep

Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
Status: Not yet recruiting Condition: Low Back Pain

A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
Status: Completed Condition: Surgery; Pain

Study to Evaluate Diphenhydramine in Children and Adolescents
Status: Completed Condition: Allergic Rhinitis

Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
Status: Completed Condition: Aphthous Stomatitis

Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
Status: Terminated Condition: Nausea; Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific

Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the Emergency Department: A Randomized Controlled Trial
Status: Completed Condition: Migraine Headaches; Nausea; Restlessness

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea
Status: Completed Condition: Nausea and Vomiting

Effect of Hyoscine and Promethazine on Labor Pain
Status: Completed Condition: Labor Pain

Diphenhydramine as an Adjunctive Sedative in Patients on Chronic Opioids
Status: Recruiting Condition: Colonoscopy; Adjunct Anesthesia Medication

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers
Status: Completed Condition: Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects.

To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
Status: Completed Condition: Nasal Congestion

Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride
Status: Completed Condition: Nasal Congestion

Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
Status: Recruiting Condition: Sedation; Endoscopy

Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Status: Recruiting Condition: Migraine

Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children
Status: Active, not recruiting Condition: Conscious Sedation

Does Thiamine Help Vomiting and Nausea in Pregnancy?
Status: Recruiting Condition: Hyperemesis Gravidarum

Promethazine vs. Lorazepam for Treatment of Vertigo
Status: Completed Condition: Peripheral Vertigo.

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED
Status: Terminated Condition: Nausea

Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers
Status: Completed Condition: Healthy

Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
Status: Completed Condition: Migraine With Aura; Migraine Without Aura

Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
Status: Completed Condition: Therapeutic Equivalence

To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions
Status: Completed Condition: Allergy

Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Status: Completed Condition: Pain, Postoperative

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Status: Completed Condition: Pain, Postoperative

A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.
Status: Completed Condition: Headache

Adjunct Sedatives in Procedures Involving Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
Status: Recruiting Condition: Endoscopic Ultrasound (EUS); Endoscopic Retrograde Cholangiopancreatography (ERCP)

Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
Status: Completed Condition: Memory, Long-Term; Memory, Short-Term

Histamine Glutamate Antagonism in Stroke
Status: Not yet recruiting Condition: Acute Cerebrovascular Accident; Cerebral Edema

Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting
Status: Completed Condition: Postoperative Nausea and Vomiting (PONV); Nausea

Ketamine as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients
Status: Recruiting Condition: Depression

Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting
Status: Terminated Condition: Ambulatory Gynecological Laparoscopic Procedures

Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil
Status: Completed Condition: Hyperalgesia

A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Status: Completed Condition: Nausea; Vomiting

Psilocybin-facilitated Treatment for Cocaine Use
Status: Recruiting Condition: Cocaine-Related Disorders

Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Status: Completed Condition: Healthy

The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study
Status: Recruiting Condition: Major Depression; Anxiety Disorder

Chicago Social Drinking Project
Status: Active, not recruiting Condition: Alcoholism

First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375
Status: Terminated Condition: Healthy Male Volunteers

Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Status: Not yet recruiting Condition: Vestibular

Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)
Status: Recruiting Condition: Kidney Cancer

Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Status: Completed Condition: Specified Sedative; Hypnotic

Simulated Driving Study in Restless Legs Syndrome
Status: Completed Condition: Restless Legs Syndrome

Effect of Benadryl Sedation During ERCP or EUS
Status: Withdrawn Condition: Gallbladder Disease; Gallstones; Pancreatitis; Abdominal Pain; Jaundice

Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
Status: Completed Condition: Nausea and Vomiting Post-foregut Surgery

Post Burn Pruritus Study in Patients Undergoing Wound Healing
Status: Completed Condition: Itching

Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation
Status: Completed Condition: Psychomotor Agitation

FUS1-nanoparticles and Erlotinib in Stage IV Lung Cancer
Status: Recruiting Condition: Lung Cancer

Safety Trial of Naproxen Sodium/ Diphenhydramine
Status: Completed Condition: Pain

The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
Status: Recruiting Condition: Neuropathic Pain

Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)
Status: Not yet recruiting Condition: Post-Operative Nausea and Vomiting; Breast Cancer

Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males
Status: Completed Condition: Healthy

Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
Status: Completed Condition: Pain

Treatment of Orthostatic Hypotension in Autonomic Failure
Status: Recruiting Condition: Autonomic Failure; Orthostatic Hypotension

Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis
Status: Not yet recruiting Condition: Inflammation; Cough; Rhinitis

Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus
Status: Completed Condition: Lupus Erythematosus, Systemic

A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Status: Recruiting Condition: Alcohol Dependence

Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis
Status: Not yet recruiting Condition: Nasal Congestion; Cough

Efficacy and Safety of the Herbal Medicine Sominex ® (Passiflora Incarnata L., Valeriana Officinalis L. and Crataegus Oxyacantha L.), Manufactured by the Laboratory EMS S / A in Patients With Psychophysiological Insomnia
Status: Not yet recruiting Condition: Insomnia

Effects of Intravenous Lidocaine on Endometriosis Pain
Status: Recruiting Condition: Endometriosis

Neural Response to Catecholamine Depletion in Subjects Suffering From Bulimia Nervosa in Their Past and Healthy Controls
Status: Recruiting Condition: Bulimia Nervosa; Eating Disorders; Dopamine; Reward; Catechol-O-methyltransferase

Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease
Status: Not yet recruiting Condition: Pompe Disease

BMS 247550 to Treat Kidney Cancer
Status: Completed Condition: Renal Cell Carcinoma

Study of Elotuzumab With Lenalidomide as Maintenance After Autologous Stem Cell Transplant (ASCT)
Status: Recruiting Condition: Myeloma

Improving Safety of Antivenom in People Bitten by Snakes
Status: Completed Condition: Snake Bites

Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)
Status: Completed Condition: Acute Mountain Sickness

Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction
Status: Not yet recruiting Condition: Liver Transplant Recipient; Living Donor (of the Respective Liver Transplant Recipient)

Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation
Status: Recruiting Condition: Liver Transplantation

Rescue Emetic Therapy for Children Having Elective Surgery
Status: Recruiting Condition: Post Operative Nausea and Vomiting; Rescue Emetic Therapy

Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer
Status: Terminated Condition: Prostate Cancer

Rapid Tranquillization Trial: TREC-India II
Status: Completed Condition: Psychotic Disorders; Aggression

The Montefiore Metoclopramide Study
Status: Completed Condition: Nausea; Extrapyramidal Symptoms

A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)
Status: Withdrawn Condition: Painful Diabetic Neuropathy

Anti-histamines and Methacholine Challenges.
Status: Completed Condition: Asthma

A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Status: Completed Condition: Chronic Idiopathic Urticaria

Metoclopramide for Migraine: A Dose Finding Study
Status: Completed Condition: Migraine

Droperidol Versus Metoclopramide for the Treatment of Primary Headaches
Status: Terminated Condition: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Status: Recruiting Condition: Acute Oral Mucositis Pain

Prophylaxis Against Metoclopramide-Induced Akathisia
Status: Completed Condition: Akathisia

Rituximab and Belimumab for Lupus Nephritis
Status: Recruiting Condition: Lupus Nephritis

Prevention of Narcotic-Induced Nausea
Status: Terminated Condition: Nausea

TPI 287 in Breast Cancer Metastatic to the Brain
Status: Recruiting Condition: Breast Cancer

Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood
Status: Completed Condition: Leukemia, Acute Myelogenous (AML); Leukemia, Acute Lymphocytic (ALL); Leukemia, Chronic Myelogenous (CML); Myelodysplastic Syndrome (MDS); Non-Hodgkin's Lymphoma (NHL)

Metoclopramide Versus Ketorolac for Tension-type Headache
Status: Completed Condition: Headache

A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
Status: Completed Condition: Healthy

Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects
Status: Completed Condition: Restless Legs Syndrome (RLS)

Multicenter Pilot Phase III Clinical Trials of JDP-205 iv Injection for the Treatment of Acute Urticaria Associated With an Acute Allergic Reaction.
Status: Completed Condition: Acute Urticaria

A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis
Status: Completed Condition: Lupus Nephritis

Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma
Status: Completed Condition: Lymphoma

A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Status: Completed Condition: Healthy

Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes
Status: Completed Condition: Cancer; Solid Tumor

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Status: Completed Condition: Lupus Erythematosus, Systemic

Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Status: Completed Condition: Vulvodynia

Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
Status: Completed Condition: Acute Migraine Headache

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
Zydus Pharms Usa
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
TABLET; ORAL040596-003Nov 18, 2005RXNo<disabled><disabled>
Watson Labs
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
TABLET; ORAL085664-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Hospira
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
INJECTABLE; INJECTION040372-002Jun 8, 2000DISCNNo<disabled><disabled>
Vintage Pharms
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
TABLET; ORAL040622-002Jul 18, 2006RXNo<disabled><disabled>
Paddock
PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride
SUPPOSITORY; RECTAL040479-001Jun 24, 2003RXNo<disabled><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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