# CETIRIZINE HYDROCHLORIDE
> **ANDA213557** · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2020-09-11
## Drug
- **FDA Application Number:** ANDA213557
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** CETIRIZINE HYDROCHLORIDE
- **Generic name:** CETIRIZINE HYDROCHLORIDE
- **Active ingredients:** CETIRIZINE HYDROCHLORIDE
- **Dosage form:** TABLET, ORALLY DISINTEGRATING
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** AUROBINDO PHARMA LTD
- **Manufacturer:** Aurohealth LLC
- **First approval:** 2020-09-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213557)
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