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Serving leading biopharmaceutical companies globally:

QuintilesIMS
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Farmers Insurance
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US Department of Justice
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McKesson
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040808

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NDA 040808 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, Able, Actavis Elizabeth, Amneal Pharm, Aurolife Pharma Llc, Bayshore Pharms 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 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-five 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-five suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 040808
Tradename:HYDROXYZINE HYDROCHLORIDE
Applicant:Amneal Pharm
Ingredient:hydroxyzine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040808
Suppliers and Packaging for NDA: 040808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040808 ANDA Blenheim Pharmacal, Inc. 10544-226 10544-226-30 30 TABLET, FILM COATED in 1 BOTTLE (10544-226-30)
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040808 ANDA Blenheim Pharmacal, Inc. 10544-226 10544-226-90 90 TABLET, FILM COATED in 1 BOTTLE (10544-226-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 24, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 24, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 24, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Accenture
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Harvard Business School
Cipla
Boehringer Ingelheim
Covington
Daiichi Sankyo
Argus Health
Moodys

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