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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 081128

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NDA 081128 describes HYDROXYZINE PAMOATE, which is a drug marketed by Barr, Beximco Pharms Usa, Duramed Pharms Barr, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Superpharm, Vangard, and Watson Labs, and is included in thirty-four NDAs. It is available from twenty-eight suppliers. Additional details are available on the HYDROXYZINE PAMOATE profile page.

The generic ingredient in HYDROXYZINE PAMOATE is hydroxyzine pamoate. There are nineteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.

Summary for 081128

Tradename:	HYDROXYZINE PAMOATE
Applicant:	Sandoz
Ingredient:	hydroxyzine pamoate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG HYDROCHLORIDE
Approval Date:	Jun 28, 1991	TE:		RLD:	No

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