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Last Updated: June 29, 2022

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, Pai Holdings Pharm, Torrent, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Biopharm, Epic Pharma Llc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Rising, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred and three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for hydroxyzine hydrochloride. Thirty-seven 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
Mongi Slim HospitalN/A
Assiut UniversityPhase 4
Istanbul Medeniyet UniversityPhase 4

See all hydroxyzine hydrochloride clinical trials

Pharmacology for hydroxyzine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for hydroxyzine hydrochloride

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
Hetero Labs Ltd Iii HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040805-003 May 29, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Quantum Pharmics HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088540-001 Oct 22, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Inds Inc HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040899-001 Jun 10, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Industries HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 089381-001 May 19, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 085247-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Solopak HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 086822-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pliva HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088619-001 Jan 10, 1986 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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