Last Updated: May 2, 2026

Details for New Drug Application (NDA): 040391

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NDA 040391 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, Apozeal Pharms, Bionpharma, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Novitium Pharma, Pai Holdings Pharm, Rising, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage, Hetero Labs Ltd Iii, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Sandoz, Somerset Theraps Llc, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred and two NDAs. It is available from fifty-one 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-one suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 040391

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Pai Holdings Pharm
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Pharmacology for NDA: 040391

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 040391

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	040391	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1034	0121-1034-16	473 mL in 1 BOTTLE (0121-1034-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	10MG/5ML
Approval Date:	Apr 10, 2002	TE:	AA	RLD:	No

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