# CETIRIZINE HYDROCHLORIDE
> **ANDA078398** · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS US · Approved 2008-06-17
## Drug
- **FDA Application Number:** ANDA078398
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** CETIRIZINE HYDROCHLORIDE
- **Generic name:** CETIRIZINE HYDROCHLORIDE
- **Active ingredients:** CETIRIZINE HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PADAGIS US
- **Manufacturer:** Padagis Israel Pharmaceuticals Ltd
- **First approval:** 2008-06-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078398)
---
*AI Analytics · CC0 1.0*