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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040787

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NDA 040787 describes HYDROXYZINE HYDROCHLORIDE, which is a drug marketed by Altana, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Luitpold, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, Hi Tech Pharma, Kv Pharm, Lannett Co Inc, Sti Pharma Llc, Vintage Pharms, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurolife Pharma Llc, Eci Pharms Llc, Elite Labs Inc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Mylan, Northstar Hlthcare, Nuvo Pharm, Nuvo Pharm 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 four NDAs. It is available from fifty-four 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-four suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 040787
Tradename:HYDROXYZINE HYDROCHLORIDE
Applicant:Kvk Tech
Ingredient:hydroxyzine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040787
Suppliers and Packaging for NDA: 040787
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040787 ANDA Liberty Pharmaceuticals, Inc. 0440-1617 N 0440-1617-12
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040787 ANDA Major Pharmaceuticals 0904-0358 N 0904-0358-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 20, 2007TE:ABRLD:No

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