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Serving leading biopharmaceutical companies globally:

Colorcon
Healthtrust
Medtronic
Cerilliant
Queensland Health
McKesson
Johnson and Johnson
Dow
Argus Health
Teva

Generated: December 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 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-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 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 0093-5062-10 1000 TABLET, FILM COATED in 1 BOTTLE (0093-5062-10)
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:

McKinsey
McKesson
Healthtrust
Accenture
UBS
Mallinckrodt
Johnson and Johnson
Federal Trade Commission
Boehringer Ingelheim
Merck

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