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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 040804


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NDA 040804 describes HYDROXYZINE HYDROCHLORIDE, which is a drug marketed by Altana, Am Regent, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, Anima, Apozeal Pharms, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Rising, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred NDAs. It is available from thirty-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. Thirty-five suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
Summary for 040804
Tradename:HYDROXYZINE HYDROCHLORIDE
Applicant:Chartwell Rx
Ingredient:hydroxyzine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040804
Mechanism of ActionHistamine Receptor Antagonists
Suppliers and Packaging for NDA: 040804
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040804 ANDA Chartwell RX, LLC 62135-545 62135-545-05 500 TABLET, FILM COATED in 1 BOTTLE (62135-545-05)
HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040804 ANDA Chartwell RX, LLC 62135-545 62135-545-12 120 TABLET, FILM COATED in 1 BOTTLE (62135-545-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 30, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jun 30, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 30, 2008TE:ABRLD:No

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