Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
US Department of Justice
Merck
Accenture
Colorcon
Fuji
Deloitte
McKinsey

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201507

« Back to Dashboard

NDA 201507 describes HYDROXYZINE PAMOATE, which is a drug marketed by Barr, 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 thirty-six 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-seven suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.
Summary for 201507
Tradename:HYDROXYZINE PAMOATE
Applicant:Heritage Pharma
Ingredient:hydroxyzine pamoate
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201507
Suppliers and Packaging for NDA: 201507
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYZINE PAMOATE hydroxyzine pamoate CAPSULE;ORAL 201507 ANDA Westwood Manufacturing 42495-170 E 42495-170-30
HYDROXYZINE PAMOATE hydroxyzine pamoate CAPSULE;ORAL 201507 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-094 N 43353-094-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG HYDROCHLORIDE
Approval Date:Jun 3, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG HYDROCHLORIDE
Approval Date:Jun 3, 2013TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Chubb
McKesson
Medtronic
Merck
Queensland Health
Teva
Boehringer Ingelheim
Mallinckrodt

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. thinkBiotech performs no independent verifification 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.