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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 210622

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NDA 210622 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Athem, Aurobindo Pharma, Cypress Pharm, Hetero Labs Ltd Iii, Lannett Co Inc, Perrigo R And D, Pharm Assoc, Quagen, Ranbaxy Labs Ltd, Taro, Torrent, Tris Pharma Inc, Jubilant Generics, Novel Labs Inc, Sandoz, and Sun Pharm, and is included in twenty NDAs. It is available from fifty-one 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 thirty-three suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 210622
Applicant:Hetero Labs Ltd Iii
Ingredient:cetirizine hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210622
Suppliers and Packaging for NDA: 210622
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 210622 ANDA A-S Medication Solutions 50090-4741 50090-4741-0 1 BOTTLE in 1 CARTON (50090-4741-0) > 118 mL in 1 BOTTLE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 210622 ANDA Camber Consumer Care 69230-316 69230-316-11 1 BOTTLE in 1 CARTON (69230-316-11) > 118 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Mar 13, 2019TE:RLD:No

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