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Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
Teva
Healthtrust
Baxter
McKesson
QuintilesIMS
Cerilliant
Farmers Insurance
Harvard Business School

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088619

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NDA 088619 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, Bayshore Pharms Llc, Purepac Pharm, Nuvo Pharm Inc, 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-three 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-three suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for NDA: 088619

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 088619

Suppliers and Packaging for NDA: 088619

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
TABLET;ORAL 088619 ANDA Teva Pharmaceuticals USA, Inc. 0093-5062 0093-5062-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-5062-01)
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
TABLET;ORAL 088619 ANDA Teva Pharmaceuticals USA, Inc. 0093-5062 0093-5062-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-5062-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 10, 1986TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
UBS
Queensland Health
Merck
Cantor Fitzgerald
McKesson
Farmers Insurance
Daiichi Sankyo
Express Scripts

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