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Serving 500+ biopharmaceutical companies globally:

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Covington
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086880

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NDA 086880 describes HYDROXYZINE HYDROCHLORIDE, which is a drug 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, Invagen Pharms, 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, Alpharma Us Pharms, Kvk Tech, Vintage Pharms, Smith And Nephew, Wockhardt, Superpharm, and Sun Pharm Inds Inc, and is included in one hundred and four NDAs. It is available from fifty suppliers. Additional details are available on the HYDROXYZINE HYDROCHLORIDE profile page.

The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for NDA: 086880

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 086880

Suppliers and Packaging for NDA: 086880

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
SYRUP;ORAL 086880 ANDA STI Pharma LLC 54879-006 54879-006-16 473 mL in 1 BOTTLE (54879-006-16)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength10MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
QuintilesIMS
Deloitte
Farmers Insurance
Julphar
Healthtrust
Cipla
US Department of Justice
Accenture

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