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Generated: November 18, 2018

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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, Amneal Pharms, Apnar Pharma Lp, 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 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
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 55315-354-31 1 BOTTLE in 1 CARTON (55315-354-31) > 120 mL in 1 BOTTLE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 090750 ANDA Aurohealth LLC 58602-028 58602-028-20 1 BOTTLE in 1 CARTON (58602-028-20) > 240 mL in 1 BOTTLE

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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