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Profile for Tradename: PAXIL CR

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Summary for Tradename: PAXIL CR

Patents:6
Applicants:1
NDAs:1
Suppliers: see list5

Pharmacology for Tradename: PAXIL CR

Clinical Trials for: PAXIL CR

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

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

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

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

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

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

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;ORAL020936Dec 6, 2000RXYes6,548,084*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Feb 16, 1999RXNo5,872,132*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Dec 6, 2000RXYes7,229,640*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Dec 6, 2000RXYes5,872,132*PED<disabled>Y<disabled>
Apotex Technologies
PAXIL CR
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL020936Dec 6, 2000RXYes6,121,291*PED<disabled>Y<disabled>
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Paragraph IV activity for: PAXIL CR

Drugname Dosage Strength RLD Submissiondate
paroxetine hydrochlorideExtended-release Tablets37.5 mgPaxil CR5/19/2009
paroxetine hydrochlorideExtended-release Tablets25 mgPaxil CR9/9/2005
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