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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
McKinsey
Deloitte
QuintilesIMS
Harvard Business School
Dow
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Fuji

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201674

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NDA 201674 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, Silarx Pharms 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 forty-seven 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. Forty-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 201674
Tradename:HYDROXYZINE HYDROCHLORIDE
Applicant:Silarx Pharms Inc
Ingredient:hydroxyzine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201674
Suppliers and Packaging for NDA: 201674
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride SYRUP;ORAL 201674 ANDA Lannett Company, Inc. 54838-502 N 54838-502-80
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride SYRUP;ORAL 201674 ANDA Preferred Pharmaceuticals, Inc. 68788-9466 N 68788-9466-4

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength10MG/5ML
Approval Date:Aug 21, 2013TE:AARLD:No

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