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Generated: April 27, 2017

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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 Vintage, Eci Pharms Llc, Elite Labs Inc, Hetero Labs Ltd Iii, Pharmafair, Luitpold, Amneal Pharm, Mutual Pharm, Solopak, Hi Tech Pharma, Ivax Pharms, Pfizer, Invagen Pharms, Organon Usa Inc, Hospira, Halsey, Pliva, Kv Pharm, Nuvo Pharm Inc, Purepac Pharm, Usl Pharma, Watson Labs, Fresenius Kabi Usa, Quantum Pharmics, Northstar Hlthcare, Sandoz, Baxter Hlthcare, Wyeth Ayerst, Able, Sun Pharm Inds, Actavis Elizabeth, Aurolife Pharma Llc, Altana, Silarx Pharms Inc, Prinston Inc, Mylan, Heritage Pharma, Sti Pharma Llc, Roerig, Alpharma Us Pharms, Kvk Tech, Vintage Pharms, Smith And Nephew, Wockhardt, Superpharm, and Sun Pharm Inds Inc, and is included in one hundred and eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: hydroxyzine hydrochloride

Drug Master File Entries: see list19
Suppliers / Packagers: see list53
Bulk Api Vendors: see list103
Clinical Trials: see list992
Patent Applications: see list6,870
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:hydroxyzine hydrochloride at DailyMed

Pharmacology for Ingredient: hydroxyzine hydrochloride

Drug ClassAntihistamine
Mechanism of ActionHistamine Receptor Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
hydroxyzine hydrochloride
INJECTABLE;INJECTION087546-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Nuvo Pharm Inc
hydroxyzine hydrochloride
TABLET;ORAL207122-001Mar 29, 2017ABRXNoNo► Subscribe► Subscribe
Watson Labs
hydroxyzine hydrochloride
TABLET;ORAL081150-001Mar 18, 1994DISCNNoNo► Subscribe► Subscribe
Invagen Pharms
hydroxyzine hydrochloride
TABLET;ORAL040812-002Mar 12, 2008ABRXNoNo► Subscribe► Subscribe
hydroxyzine hydrochloride
INJECTABLE;INJECTION087273-002Apr 20, 1982DISCNNoNo► Subscribe► Subscribe
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