# CETIRIZINE HYDROCHLORIDE ALLERGY
> **ANDA078317** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2007-12-27
## Drug
- **FDA Application Number:** ANDA078317
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** CETIRIZINE HYDROCHLORIDE ALLERGY
- **Generic name:** CETIRIZINE HCL 10 MG
- **Active ingredients:** CETIRIZINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** APOTEX INC
- **Manufacturer:** Allegiant Health
- **First approval:** 2007-12-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078317)
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