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Generated: May 29, 2017

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Sertraline hydrochloride - Generic Drug Details

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What are the generic sources for sertraline hydrochloride and what is the scope of sertraline hydrochloride freedom to operate?

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

Sertraline hydrochloride has forty-eight patent family members in forty-five countries.

There are twenty-two drug master file entries for sertraline hydrochloride. Sixty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: sertraline hydrochloride

Drug Master File Entries: see list22
Suppliers / Packagers: see list62
Bulk Api Vendors: see list68
Clinical Trials: see list1,090
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sertraline hydrochloride at DailyMed

Pharmacology for Ingredient: sertraline hydrochloride

Tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Frontida Biopharm
sertraline hydrochloride
TABLET;ORAL077818-001Feb 6, 2007DISCNNoNo► Subscribe► Subscribe
Ranbaxy Labs Ltd
sertraline hydrochloride
CONCENTRATE;ORAL078053-001Feb 5, 2007DISCNNoNo► Subscribe► Subscribe
Sun Pharm Inds (in)
sertraline hydrochloride
TABLET;ORAL078108-001Feb 6, 2007ABRXNoNo► Subscribe► Subscribe
Oxford Pharms
sertraline hydrochloride
TABLET;ORAL078175-003Jul 21, 2010ABRXNoNo► Subscribe► Subscribe
sertraline hydrochloride
TABLET;ORAL078403-003Jan 8, 2008ABRXNoNo► Subscribe► Subscribe
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