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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 040812

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NDA 040812 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 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 suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 040812

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Somerset Theraps Llc
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 12, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 12, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Mar 12, 2008	TE:		RLD:	No

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