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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091130

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NDA 091130 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Athem, Aurobindo Pharma, Cypress Pharm, Lannett Co Inc, Perrigo R And D, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Torrent, Tris Pharma Inc, Jubilant Generics, and Sun Pharm, and is included in fifteen NDAs. It is available from forty-one 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 fifty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 091130
Tradename:CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Lannett Co Inc
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091130
Suppliers and Packaging for NDA: 091130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 091130 ANDA A-S Medication Solutions 50090-4379 50090-4379-0 120 mL in 1 CARTON (50090-4379-0)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 091130 ANDA Lannett Company, Inc. 54838-552 54838-552-40 120 mL in 1 CARTON (54838-552-40)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Apr 22, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Apr 22, 2011TE:RLD:No

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