# ZYRTEC-D 12 HOUR
> **NDA021150** · New Drug Application · Sponsor: KENVUE BRANDS · Approved 2001-08-10
## Drug
- **FDA Application Number:** NDA021150
- **Application type:** New Drug Application
- **Brand name:** ZYRTEC-D 12 HOUR
- **Generic name:** CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- **Active ingredients:** CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** KENVUE BRANDS
- **Manufacturer:** Kenvue Brands LLC
- **First approval:** 2001-08-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021150)
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