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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091176

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NDA 091176 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 091176
Tradename:HYDROXYZINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:hydroxyzine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091176
Suppliers and Packaging for NDA: 091176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 091176 ANDA Mylan Pharmaceuticals Inc. 0378-2586 0378-2586-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2586-01)
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 091176 ANDA Mylan Pharmaceuticals Inc. 0378-2586 0378-2586-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2586-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 7, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jun 7, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 7, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
McKinsey
Merck
Johnson and Johnson
Dow
Accenture
Farmers Insurance
Citi
Deloitte

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