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Details for Generic Name: paroxetine hydrochloride

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Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Apotex Technologies, Apotex Inc, Mylan, Prinston Inc, Apotex, Aurobindo Pharma, Mylan Pharms Inc, Prosam Labs, Roxane, Sandoz, Sun Pharm Inds Inc, Teva, Teva Pharms, and Zydus Pharms Usa, and is included in nineteen NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for paroxetine hydrochloride. Five suppliers are listed for this compound.

Summary for Generic Name: paroxetine hydrochloride

Tradenames:4
Patents:11
Applicants:14
NDAs:19
Drug Master File Entries: see list28
Suppliers: see list5
Therapeutic Class:Antidepressants
Anxiolytics

Pharmacology for Ingredient: paroxetine hydrochloride

Clinical Trials for: paroxetine hydrochloride

Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
Status: Completed Condition: Postmenopausal Symptoms

Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
Status: Terminated Condition: Depressive Disorder

Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Status: Completed Condition: Hot Flashes

24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Status: Completed Condition: Hot Flashes

Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
Status: Completed Condition: Postmenopausal Symptoms

Interaction Between Paroxetine and Telaprevir
Status: Terminated Condition: Hepatitis C Infection; Depression

PAXIL CR Bioequivalence Study
Status: Completed Condition: Two Single Doses of Controlled Release Paroxetine Given 14 Days Apart; Depressive Disorder; Healthy Volunteer

Paroxetine Hydrochloride 40 mg Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

Combination Of PAXIL Tablet And Benzodiazepines
Status: Completed Condition: Mental Disorders

Study of Paxil Use in Menopausal Women
Status: Completed Condition: Menopause

Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects
Status: Completed Condition: Depressive Disorder; Healthy Volunteer

Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
Status: Completed Condition: Premature Ejaculation

Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
Status: Completed Condition: Pharmacokinetics; Depressive Disorder

Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome
Status: Completed Condition: Fibromyalgia Syndrome

Prazosin vs. Paroxetine in Combat Stress Symptoms in OIF/OEF Returnees
Status: Completed Condition: Sleep Disorders; Stress Disorders, Post-Traumatic

A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
Status: Completed Condition: Drug-drug Interaction

Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement
Status: Recruiting Condition: Major Depression

Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
Status: Completed Condition: Depressive Disorder

Paxil CR Bioequivalence Study Brazil - Fed Administration
Status: Completed Condition: Depressive Disorder; Healthy Volunteers

Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
Status: Terminated Condition: Post-Traumatic Stress Disorder

A Local Register Study For Major Depression Of Paroxetine Controlled Release
Status: Completed Condition: Depressive Disorder, Major; Major Depressive Disorder (MDD)

Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
Status: Completed Condition: Stress Disorders, Post-Traumatic

Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder
Status: Recruiting Condition: HIV Associated Neurocognitive Disorder

A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers
Status: Completed Condition: Healthy

Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
Status: Completed Condition: Panic Disorder

Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance
Status: Terminated Condition: Stress Disorders, Post-Traumatic; Sleep Disorders

Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects
Status: Completed Condition: Depressive Disorder; Healthy Volunteer

Lithium Versus Paroxetine in Major Depression
Status: Not yet recruiting Condition: Major Depressive Disorder

Study of PET Scans and Serotonin in Hot Flashes Treatment
Status: Terminated Condition: Hot Flashes

Changes of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder
Status: Completed Condition: Panic Disorder

Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo
Status: Recruiting Condition: Healthy

Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
Status: Completed Condition: Healthy

Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
Status: Completed Condition: Healthy

Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
Status: Completed Condition: Social Phobia

Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
Status: Completed Condition: Healthy

Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
Status: Completed Condition: Healthy

Duloxetine Versus Paroxetine for Major Depression
Status: Completed Condition: Major Depressive Disorder

Type II Diabetes Mellitus in Patients Exposed to Pravastatin and Paroxetine
Status: Completed Condition: Depression, Postpartum

Effects of Paxil CR on Neural Circuits in Posttraumatic Stress Disorder (PTSD)
Status: Completed Condition: Posttraumatic Stress Disorder (PTSD)

Paroxetines Effect on Tramadols Metabolism and Pharmakodynamics: a Dose Response Study
Status: Active, not recruiting Condition: Depression; Pain

Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.
Status: Completed Condition: Tinnitus

Luteal Phase Administration of Paroxetine for the Treatment of PMDD
Status: Completed Condition: Premenstrual Dysphoric Disorder

Quetiapine Augmentation for Treatment-resistant PTSD
Status: Completed Condition: Combat Disorders; Stress Disorders, Post-Traumatic

Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain
Status: Completed Condition: Neuropathic Pain; Multiple Sclerosis

Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients
Status: Withdrawn Condition: Depressive Disorder

A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
Status: Completed Condition: Pharmacokinetics; Depressive Disorder

Drug Use Investigation for PAXIL Tablet
Status: Completed Condition: Mental Disorders

Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression
Status: Terminated Condition: Depression

Study of Antidepressants in Parkinson's Disease
Status: Completed Condition: Parkinson Disease; Depression

Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects
Status: Completed Condition: Healthy Volunteers

RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo
Status: Completed Condition: Phobic Disorders

Long-term Study Of Paroxetine in Women and Men
Status: Completed Condition: Social Phobia

A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
Status: Completed Condition: Major Depressive Disorder

Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder
Status: Completed Condition: Panic Disorders

Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)
Status: Completed Condition: Panic Disorder

Special Drug Use Investigation for PAXIL Tablet (Long-term)
Status: Completed Condition: Mental Disorders

Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)
Status: Completed Condition: Mental Disorders

Interaction Study of Timolol Eye Drops and Paroxetine Capsules
Status: Completed Condition: Healthy

Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Status: Completed Condition: Anxiety Disorder

Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
Status: Enrolling by invitation Condition: Major Depressive Disorder

Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene
Status: Recruiting Condition: Anovulation; Disorder Due Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP3A Enzyme Deficiency

Paroxetine - Controlled Release in the Treatment of Irritable Bowel Syndrome (IBS)
Status: Completed Condition: Irritable Bowel Syndrome

BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder
Status: Completed Condition: Post-Traumatic Stress Disorder

Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
Status: Completed Condition: Social Anxiety Disorder; Social Phobia; Alcohol Use Disorder; Alcohol Abuse; Alcohol Dependence

Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study
Status: Recruiting Condition: Depression; Suicidal Ideation

Vilazodone for Treatment of Geriatric Depression
Status: Recruiting Condition: Major Depressive Disorder

Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
Status: Completed Condition: Coronary Artery Disease

Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Status: Completed Condition: Social Anxiety Disorder

A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria
Status: Completed Condition: Premenstrual Dysphoric Disorder; Premenstrual Syndrome

A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder
Status: Completed Condition: Panic Disorder

Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
Status: Active, not recruiting Condition: PTSD

Social Anxiety Disorder Study Of Paroxetine
Status: Completed Condition: Social Phobia

Paroxetine in the Treatment of Chronic Primary Insomnia
Status: Completed Condition: Primary Insomnia; Depression

Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or Suicide
Status: Terminated Condition: Major Depressive Disorder

Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy
Status: Completed Condition: Stress Disorders, Post-Traumatic

Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression
Status: Completed Condition: Panic Disorder

Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers
Status: Completed Condition: Healthy

Treatment of Depression in Parkinson's Disease Trial
Status: Completed Condition: Parkinson Disease; Depression

Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder
Status: Completed Condition: Post Traumatic Stress Disorder

Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin
Status: Completed Condition: Chronic Hepatitis C

Special Drug Use Investigation for PAXIL Tablet (Investigation in Case of Administered From 20mg/Day)
Status: Completed Condition: Panic Disorder

An Eight-Week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
Status: Completed Condition: Depressive Disorder, Major

Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Status: Completed Condition: Depression

Randomized,Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder
Status: Recruiting Condition: Major Depression Disorder

MDD POC Study GSK372475 Subjects Depressive Disease
Status: Completed Condition: Depressive Disorder

Paxil CR Bioequivalence Study Brazil
Status: Completed Condition: Depressive Disorder; Healthy Volunteers

Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder
Status: Terminated Condition: Anxiety Disorders

Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Status: Completed Condition: Posttraumatic Stress Disorder

Paroxetine Treatment in Outpatients With Comorbid PTSD and Substance Dependence
Status: Completed Condition: PTSD

Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
Status: Completed Condition: Depressive Disorder, Major

Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
Status: Completed Condition: Anxiety Disorders

Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C
Status: Completed Condition: Hepatitis C; Depression; Interferon-alpha Associated Side Effects

Study Of Generalized Anxiety Disorder
Status: Completed Condition: Anxiety Disorder; Anxiety Disorders

Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine
Status: Completed Condition: Major Depression

Risperidone vs. Paroxetine for Panic Attacks
Status: Terminated Condition: Major Depressive Disorder With Panic Attacks; Panic Disorder

Comparing Paroxetine and Duloxetine on Cardiovascular Measures
Status: Completed Condition: Depressive Symptoms

Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy
Status: Completed Condition: Stress Disorders, Post-Traumatic

A Single-Blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks
Status: Completed Condition: Major Depression With Panic Attacks; Panic Disorder

A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder
Status: Completed Condition: Anxiety Disorders; Social Anxiety Disorder

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
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Feb 16, 1999RXNo5,900,423*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL
paroxetine hydrochloride
TABLET;ORAL020031Dec 29, 1992RXYes6,133,289*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Feb 16, 1999RXNo6,121,291*PED<disabled>Y<disabled>
Teva
PAROXETINE HYDROCHLORIDE
paroxetine hydrochloride
TABLET;ORAL076618Aug 15, 2005RXNo<disabled><disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Feb 16, 1999RXNo6,133,289*PED<disabled>Y<disabled>
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