# AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY
> **ANDA216421** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2024-05-29
## Drug
- **FDA Application Number:** ANDA216421
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY
- **Generic name:** AZELASTINE HYDROCHLORIDE
- **Active ingredients:** AZELASTINE HYDROCHLORIDE
- **Dosage form:** SPRAY, METERED
- **Route:** NASAL
- **Marketing status:** Over-the-counter
- **Sponsor:** APOTEX
- **Manufacturer:** Allegiant Health
- **First approval:** 2024-05-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216421)
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