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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040156


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NDA 040156 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-seven 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.
Summary for 040156
Tradename:HYDROXYZINE PAMOATE
Applicant:Impax Labs Inc
Ingredient:hydroxyzine pamoate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040156
Mechanism of ActionHistamine Receptor Antagonists
Suppliers and Packaging for NDA: 040156
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE PAMOATE hydroxyzine pamoate CAPSULE;ORAL 040156 ANDA Amneal Pharmaceuticals of New York LLC 0115-1803 0115-1803-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-01)
HYDROXYZINE PAMOATE hydroxyzine pamoate CAPSULE;ORAL 040156 ANDA Amneal Pharmaceuticals of New York LLC 0115-1803 0115-1803-02 500 CAPSULE in 1 BOTTLE, PLASTIC (0115-1803-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG HYDROCHLORIDE
Approval Date:Jul 15, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG HYDROCHLORIDE
Approval Date:Jul 15, 1996TE:ABRLD:No

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