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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 210634

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NDA 210634 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, Anima, Apozeal Pharms, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Rising, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred NDAs. It is available from forty-seven 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-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

Summary for 210634

Tradename:	HYDROXYZINE HYDROCHLORIDE
Applicant:	Apozeal Pharms
Ingredient:	hydroxyzine hydrochloride
Patents:	0

Pharmacology for NDA: 210634

Mechanism of Action	Histamine Receptor Antagonists

Suppliers and Packaging for NDA: 210634

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	SYRUP;ORAL	210634	ANDA	APOZEAL PHARMACEUTICALS INC	83745-232	83745-232-16	473 mL in 1 BOTTLE (83745-232-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYRUP;ORAL			Strength	10MG/5ML
Approval Date:	Feb 26, 2019	TE:	AA	RLD:	No

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