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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 040808

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NDA 040808 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, Pai Holdings Pharm, Rising, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage Pharma, 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 one NDAs. It is available from forty-nine 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. Forty-nine suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 040808

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Amneal Pharm
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Pharmacology for NDA: 040808

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 040808

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040808	ANDA	Amneal Pharmaceuticals LLC	65162-575	65162-575-10	100 TABLET, FILM COATED in 1 BOTTLE (65162-575-10)
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040808	ANDA	Amneal Pharmaceuticals LLC	65162-575	65162-575-11	1000 TABLET, FILM COATED in 1 BOTTLE (65162-575-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 24, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 24, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 24, 2008	TE:	AB	RLD:	No

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