# LEVOCETIRIZINE DIHYDROCHLORIDE
> **ANDA211528** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2018-11-02
## Drug
- **FDA Application Number:** ANDA211528
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LEVOCETIRIZINE DIHYDROCHLORIDE
- **Generic name:** Levocetirizine Dihydrochloride
- **Active ingredients:** LEVOCETIRIZINE DIHYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** APOTEX INC
- **First approval:** 2018-11-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211528)
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