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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204226

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NDA 204226 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, 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, Novel Labs Inc, Sandoz, and Sun Pharma Global, and is included in eighteen NDAs. It is available from sixty-three suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 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 204226
Applicant:Perrigo R And D
Ingredient:cetirizine hydrochloride
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 204226
Suppliers and Packaging for NDA: 204226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 204226 ANDA L. Perrigo Company 0113-0189 0113-0189-26 1 BOTTLE in 1 CARTON (0113-0189-26) > 118 mL in 1 BOTTLE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 204226 ANDA L. Perrigo Company 0113-0503 0113-0503-26 1 BOTTLE in 1 CARTON (0113-0503-26) > 118 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Sep 9, 2013TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Daiichi Sankyo
Fish and Richardson

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