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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040786

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NDA 040786 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 040786

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

Pharmacology for NDA: 040786

Suppliers and Packaging for NDA: 040786

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040786 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1525 0615-1525-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-1525-39)
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040786 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1526 0615-1526-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-1526-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 20, 2007TE:ABRLD:No


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