# CETIRIZINE HYDROCHLORIDE
> **ANDA218895** · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2024-10-03
## Drug
- **FDA Application Number:** ANDA218895
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** CETIRIZINE HYDROCHLORIDE
- **Generic name:** CETIRIZINE HYDROCHLORIDE
- **Active ingredients:** CETIRIZINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** REGCON HOLDINGS
- **Manufacturer:** Indoco Remedies Limited
- **First approval:** 2024-10-03
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218895)
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