# CETIRIZINE HYDROCHLORIDE
> **ANDA078412** · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 2008-06-18
## Drug
- **FDA Application Number:** ANDA078412
- **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:** PHARM ASSOC
- **Manufacturer:** PAI Holdings, LLC dba PAI Pharma
- **First approval:** 2008-06-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078412)
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