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Last Updated: August 15, 2020

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Hydroxyzine hydrochloride - Generic Drug Details

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

Hydroxyzine hydrochloride is the generic ingredient in five branded drugs marketed by Baxter Hlthcare, Altana, Am Regent, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Organon Usa Inc, Pfizer, Roerig, Alpharma Us Pharms, Anima, Hi Tech Pharma, Kv Pharm, Lannett Co Inc, Torrent, Vintage Pharms, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Eci Pharms Llc, Epic Pharma Llc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Mylan, Northstar Hlthcare, Nuvo Pharm, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Usl Pharma, and Vintage, and is included in one hundred and seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for hydroxyzine hydrochloride. Thirty-seven suppliers are listed for this compound.

Recent Clinical Trials for hydroxyzine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityPhase 4
Istanbul Medeniyet UniversityPhase 4
University of WashingtonPhase 4

See all hydroxyzine hydrochloride clinical trials

Pharmacology for hydroxyzine hydrochloride
Drug ClassAntihistamine
Mechanism of ActionHistamine Receptor Antagonists

US Patents and Regulatory Information for hydroxyzine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purepac Pharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088121-001 Sep 25, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Usl Pharma HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 089121-001 Mar 20, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Alpharma Us Pharms HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride SYRUP;ORAL 088785-001 Feb 3, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087603-001 Jan 22, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Organon Usa Inc ORGATRAX hydroxyzine hydrochloride INJECTABLE;INJECTION 087014-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer ATARAX hydroxyzine hydrochloride TABLET;ORAL 010392-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Heritage Pharma HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 204279-003 Aug 20, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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