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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, Ranbaxy, Sandoz, Sun Pharm Inds (in), 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: see list13
Therapeutic Class:Antidepressants

Pharmacology for Ingredient: sertraline hydrochloride

Tentative approvals for SERTRALINE HYDROCHLORIDE

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

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
Mutual Pharm
sertraline hydrochloride
TABLET;ORAL077818Feb 6, 2007DISCNNo<disabled><disabled>
sertraline hydrochloride
TABLET;ORAL019839Dec 30, 1991RXNo<disabled><disabled>
Austarpharma Llc
sertraline hydrochloride
TABLET;ORAL078677Mar 4, 2009RXNo<disabled><disabled>
sertraline hydrochloride
CONCENTRATE;ORAL020990Dec 7, 1999RXYes6,727,283*PED<disabled>Y<disabled>
Prosam Labs
sertraline hydrochloride
TABLET;ORAL078175Jul 21, 2010RXNo<disabled><disabled>
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