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Serving leading biopharmaceutical companies globally:

Queensland Health
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McKinsey
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US Department of Justice
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Healthtrust
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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040574

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NDA 040574 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: 040574

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

Pharmacology for NDA: 040574

Suppliers and Packaging for NDA: 040574

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
TABLET;ORAL 040574 ANDA A-S Medication Solutions LLC 50090-0124 50090-0124-0 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0124-0)
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
TABLET;ORAL 040574 ANDA A-S Medication Solutions LLC 50090-0124 50090-0124-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0124-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 27, 2005TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
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Cantor Fitzgerald
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