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Last Updated: March 29, 2024

Hydroxyzine hydrochloride - Generic Drug Details


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What are the generic 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, Apozeal Pharms, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, 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 four NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for hydroxyzine hydrochloride. Thirty-five 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
Sultan Qaboos UniversityPhase 4
Minia UniversityPhase 1
Mongi Slim HospitalN/A

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
Hospira HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 087546-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VISTARIL hydroxyzine hydrochloride INJECTABLE;INJECTION 011111-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Smith And Nephew HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 087592-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kv Pharm HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087821-001 Jun 23, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 089383-001 May 19, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pliva HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088619-001 Jan 10, 1986 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 087274-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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