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Last Updated: June 19, 2021

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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, Akorn, Alpharma Us Pharms, Anima, Kv Pharm, Lannett Co Inc, Torrent, Vintage Pharms, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Discovery Therap, Epic Pharma Llc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Mylan, Northstar Hlthcare, 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 three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for hydroxyzine hydrochloride
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
Watson Labs HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 086836-001 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Invagen Pharms HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040812-001 Mar 12, 2008 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Invagen Pharms HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040812-002 Mar 12, 2008 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Superpharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088795-001 Dec 5, 1984 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Pharmafair HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 088862-001 Feb 14, 1986 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Heritage Pharma HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 204279-003 Aug 20, 2014 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>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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Serving leading biopharmaceutical companies globally:

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