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

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Moodys
Citi
Express Scripts
Cerilliant
Healthtrust
Cantor Fitzgerald
Boehringer Ingelheim
Johnson and Johnson

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076601

« Back to Dashboard

NDA 076601 describes CETIRIZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Lannett Co Inc, Perrigo R And D, Ranbaxy Labs Ltd, Taro, Teva Pharms, Vintage, Wockhardt, Bionpharma Inc, Strides Pharma, Sun Pharm Inds Inc, Actavis Elizabeth, Amneal Pharms Ny, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Granules India Ltd, Ipca Labs Ltd, Jubilant Cadista, Mylan, Orchid Hlthcare, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique Pharm Labs, and Ivax Sub Teva Pharms, and is included in forty-three NDAs. It is available from thirteen suppliers. Additional details are available on the CETIRIZINE HYDROCHLORIDE profile page.

The generic ingredient in CETIRIZINE HYDROCHLORIDE is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.
Summary for 076601
Tradename:CETIRIZINE HYDROCHLORIDE
Applicant:Taro
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076601
Medical Subject Heading (MeSH) Categories for 076601
Suppliers and Packaging for NDA: 076601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride SYRUP;ORAL 076601 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4070 N 51672-4070-8

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Jun 20, 2008TE:AARLD: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:

Farmers Insurance
Fish and Richardson
QuintilesIMS
McKinsey
Moodys
Colorcon
Federal Trade Commission
Queensland Health
McKesson

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.