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Details for Generic Name: sertraline hydrochloride

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Summary for Generic Name: sertraline hydrochloride

Drug Master File Entries: see list22
Suppliers: see list13
Therapeutic Class:Antidepressants

Pharmacology for Ingredient: sertraline hydrochloride

Tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG
<disabled><disabled>TABLET; ORAL200MG

Clinical Trials for: sertraline hydrochloride

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

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

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

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
TABLET;ORAL076881Feb 6, 2007DISCNNo<disabled><disabled>
Prosam Labs
sertraline hydrochloride
TABLET;ORAL078175Jul 21, 2010RXNo<disabled><disabled>
sertraline hydrochloride
CONCENTRATE;ORAL076934Jun 30, 2006DISCNNo<disabled><disabled>
Actavis Elizabeth
sertraline hydrochloride
TABLET;ORAL077345Feb 6, 2007DISCNNo<disabled><disabled>
sertraline hydrochloride
TABLET;ORAL077670Feb 6, 2007RXNo<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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