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Profile for Tradename: ZOLOFT

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Zoloft is a drug marketed by Pfizer and is included in two NDAs. It is available from thirteen suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the sertraline hydrochloride profile page.

Summary for Tradename: ZOLOFT

Suppliers / Packagers: see list85

Pharmacology for Tradename: ZOLOFT

Clinical Trials for: ZOLOFT

Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects
Status: Completed Condition: Healthy

Sertraline Compared With Hypericum Perforatum (St.John's Wort) in Treating Depression
Status: Completed Condition: Depression; Unspecified Adult Solid Tumor, Protocol Specific

An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia
Status: Completed Condition: Depression

Special Investigation Of Long Term Use Of Sertraline.
Status: Completed Condition: Depression; Panic Disorder

Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery
Status: Active, not recruiting Condition: Roux en Y Gastric Bypass Surgery

Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions
Status: Completed Condition: Healthy

Special Investigation Of J Zoloft For Panic Disorder Patients
Status: Completed Condition: Panic Disorder

A Trial of Sertraline in Young Children With Autism Spectrum Disorder
Status: Recruiting Condition: Autism Spectrum Disorder

Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
Status: Completed Condition: Healthy

Courtesy of
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
sertraline hydrochloride
CONCENTRATE;ORAL020990-001Dec 7, 1999RXYes7,067,555*PED<disabled>Y<disabled>
sertraline hydrochloride
TABLET;ORAL019839-004Dec 30, 1991DISCNNo<disabled><disabled>
sertraline hydrochloride
TABLET;ORAL019839-001Dec 30, 1991RXNo<disabled><disabled>
sertraline hydrochloride
CONCENTRATE;ORAL020990-001Dec 7, 1999RXYes6,727,283*PED<disabled>Y<disabled>
sertraline hydrochloride
TABLET;ORAL019839-005Mar 6, 1996RXNo<disabled><disabled>
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Paragraph IV activity for: ZOLOFT

Drugname Dosage Strength RLD Submissiondate
sertraline hydrochlorideTablets150 mg and 200 mgZoloft11/9/2005
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Preferred citation:

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

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