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Generated: May 22, 2017

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Cetirizine hydrochloride - Generic Drug Details

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What are the generic drug sources for cetirizine hydrochloride and what is the scope of cetirizine hydrochloride patent protection?

Cetirizine hydrochloride
is the generic ingredient in thirteen branded drugs marketed by Cypress Pharm, Taro, Apotex Inc, Actavis Elizabeth, Jubilant Generics, Actavis Mid Atlantic, Cipla Ltd, J And J Consumer Inc, Perrigo R And D, Allied Pharma Inc, Wockhardt, Bionpharma Inc, Unique Pharm Labs, Silarx, Sun Pharm Inds Inc, Jubilant Cadista, Sun Pharma Global, Dr Reddys Labs Ltd, Sandoz, Contract Pharmacal, Aurobindo Pharma, Aurobindo Pharma Ltd, Orchid Hlthcare, Amneal Pharms, Bio Pharm Inc, Ranbaxy Labs Ltd, Tris Pharma Inc, Ipca Labs Ltd, Mylan, Teva Pharms, Amneal Pharms Ny, Unichem, Breckenridge Pharm, Par Pharm Inc, Torrent Pharms Llc, Novel Labs Inc, Vintage, Sun Pharm Inds Ltd, and Ivax Sub Teva Pharms, and is included in sixty-five NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Cetirizine hydrochloride has twenty-two patent family members in nineteen countries.

There are thirty-nine drug master file entries for cetirizine hydrochloride. One hundred and sixty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: cetirizine hydrochloride

Drug Master File Entries: see list39
Suppliers / Packagers: see list161
Bulk Api Vendors: see list147
Clinical Trials: see list1,004
Patent Applications: see list4,810
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cetirizine hydrochloride at DailyMed

Pharmacology for Ingredient: cetirizine hydrochloride

Tentative approvals for CETIRIZINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe5MG/5MLSYRUP;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc
cetirizine hydrochloride
TABLET;ORAL077499-003Dec 27, 2007OTCNoNo► Subscribe► Subscribe
J And J Consumer Inc
cetirizine hydrochloride
SYRUP;ORAL020346-001Sep 27, 1996DISCNNoNo► Subscribe► Subscribe
Ipca Labs Ltd
cetirizine hydrochloride
TABLET;ORAL202277-003Mar 11, 2014OTCNoNo► Subscribe► Subscribe
cetirizine hydrochloride
TABLET;ORAL078072-003Jul 22, 2009OTCNoNo► Subscribe► Subscribe
cetirizine hydrochloride
TABLET;ORAL076677-002Dec 27, 2007OTCNoNo► Subscribe► Subscribe
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