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Boehringer Ingelheim
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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090750

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NDA 090750 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Actavis Mid Atlantic, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Cypress Pharm, Lannett Co Inc, Perrigo R And D, Ranbaxy Labs Ltd, Taro, Tris Pharma Inc, Jubilant Generics, and Sun Pharma Global, and is included in fifteen NDAs. It is available from forty-five suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 090750
Tradename:CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Aurobindo Pharma
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090750
Suppliers and Packaging for NDA: 090750
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 090750 ANDA Fred's, Inc. 55315-354 N 55315-354-31
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 090750 ANDA Aurohealth LLC 58602-028 N 58602-028-20

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Feb 2, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Feb 2, 2010TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
UBS
Argus Health
Harvard Business School
US Army
QuintilesIMS
Farmers Insurance
Johnson and Johnson
Federal Trade Commission

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