# CHILDREN'S ZYRTEC ALLERGY
> **NDA021621** · New Drug Application · Sponsor: KENVUE BRANDS · Approved 2004-03-16
## Drug
- **FDA Application Number:** NDA021621
- **Application type:** New Drug Application
- **Brand name:** CHILDREN'S ZYRTEC ALLERGY
- **Generic name:** CETIRIZINE HYDROCHLORIDE
- **Active ingredients:** CETIRIZINE HYDROCHLORIDE
- **Dosage form:** TABLET, CHEWABLE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** KENVUE BRANDS
- **Manufacturer:** Kenvue Brands LLC
- **First approval:** 2004-03-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021621)
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