Last Updated: May 3, 2026

Details for New Drug Application (NDA): 219289

✉ Email this page to a colleague

« Back to Dashboard

NDA 219289 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 219289

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Bionpharma
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Pharmacology for NDA: 219289

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 219289

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	219289	ANDA	Bionpharma Inc.	69452-395	69452-395-88	473 mL in 1 BOTTLE (69452-395-88)
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	219289	ANDA	Kesin Pharma	81033-031	81033-031-44	40 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	10MG/5ML
Approval Date:	Apr 28, 2025	TE:	AA	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.