Last Updated: August 5, 2026

Details for New Drug Application (NDA): 201674

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NDA 201674 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, Saptalis Pharms, 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 three NDAs. It is available from fifty-four 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-four suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 201674

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Lannett Co Inc
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Pharmacology for NDA: 201674

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 201674

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	201674	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0507	17856-0507-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0507-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0507-2)
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	201674	ANDA	Lannett Company, Inc.	54838-502	54838-502-80	473 mL in 1 BOTTLE, PLASTIC (54838-502-80)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	10MG/5ML
Approval Date:	Aug 21, 2013	TE:	AA	RLD:	No

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