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Generated: January 20, 2018

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, Allied Pharma Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Cypress Pharm, Perrigo R And D, Ranbaxy Labs Ltd, Silarx, Taro, Tris Pharma Inc, Jubilant Generics, and Sun Pharma Global, and is included in fifteen NDAs. It is available from forty-seven 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-seven 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:Silarx
Ingredient:cetirizine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
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 Silarx Pharmaceuticals, Inc 54838-552 54838-552-40 120 mL in 1 CARTON (54838-552-40)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 091130 ANDA Silarx Pharmaceuticals, Inc 54838-559 54838-559-40 120 mL in 1 CARTON (54838-559-40)

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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