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Details for Generic Name: sertraline hydrochloride

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Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Ranbaxy Labs Ltd, Roxane, Pfizer, Accord Hlthcare, Actavis Elizabeth, Apotex Inc, Austarpharma Llc, Cipla Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mutual Pharm, Mylan, Mylan Pharms Inc, Pliva Hrvatska Doo, Prosam Labs, Sandoz, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Torrent Pharms, Watson Labs, Wockhardt, and Zydus Pharms Usa, and is included in thirty-one NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for sertraline hydrochloride. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sertraline hydrochloride

Drug Master File Entries: see list22
Suppliers / Packaging: see list85
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

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

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

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

A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
Status: Completed Condition: Healthy

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

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
Prosam Labs
sertraline hydrochloride
TABLET;ORAL078175-002Jul 21, 2010RXNo<disabled><disabled>
sertraline hydrochloride
TABLET;ORAL078403-003Jan 8, 2008RXNo<disabled><disabled>
Prosam Labs
sertraline hydrochloride
TABLET;ORAL078175-003Jul 21, 2010RXNo<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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