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Last Updated: November 2, 2024

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 Amneal Pharms, Apozeal Pharms, Aurobindo Pharma, Bajaj, Chartwell Molecular, Chartwell Rx, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Pharm Assoc, Quagen, Ranbaxy Labs Ltd, Taro, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharm, and is included in twenty NDAs. It is available from forty-six 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-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 204226
Pharmacology for NDA: 204226
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 SOLUTION;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 SOLUTION;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:SOLUTION;ORALStrength5MG/5ML
Approval Date:Sep 9, 2013TE:RLD:No

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