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Generated: May 27, 2017

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Paroxetine hydrochloride - Generic Drug Details

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

Paroxetine hydrochloride
is the generic ingredient in four branded drugs marketed by Mylan, Aurobindo Pharma, Apotex Technologies, Mylan Pharms Inc, Teva, Roxane, Jubilant Generics, Lupin Ltd, Kremers Urban Pharms, Prinston Inc, Apotex, Upsher-smith Labs, Oxford Pharms, Teva Pharms, Zydus Pharms Usa, Sun Pharm Inds Inc, and Apotex Inc, and is included in twenty-two NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Paroxetine hydrochloride has two hundred and thirteen patent family members in fifty-one countries.

There are thirty drug master file entries for paroxetine hydrochloride. Fifty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: paroxetine hydrochloride

Drug Master File Entries: see list30
Suppliers / Packagers: see list54
Bulk Api Vendors: see list107
Clinical Trials: see list1,043
Patent Applications: see list5,735
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:paroxetine hydrochloride at DailyMed

Pharmacology for Ingredient: paroxetine hydrochloride

Tentative approvals for PAROXETINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 10MG BASETABLET;ORAL
► Subscribe► SubscribeEQ 40MG BASETABLET;ORAL
► Subscribe► SubscribeEQ 30MG BASETABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Generics
paroxetine hydrochloride
TABLET;ORAL205528-001Nov 27, 2015ABRXNoNo► Subscribe► Subscribe
Zydus Pharms Usa
paroxetine hydrochloride
TABLET;ORAL077584-001Mar 7, 2007ABRXNoNo► Subscribe► Subscribe
Lupin Ltd
paroxetine hydrochloride
TABLET, EXTENDED RELEASE;ORAL204134-002Jan 20, 2017ABRXNoNo► Subscribe► Subscribe
Jubilant Generics
paroxetine hydrochloride
TABLET;ORAL205528-002Nov 27, 2015ABRXNoNo► Subscribe► Subscribe
Oxford Pharms
paroxetine hydrochloride
TABLET;ORAL076968-001Jun 21, 2010ABRXNoNo► Subscribe► Subscribe
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