# AZELASTINE HYDROCHLORIDE
> **ANDA077954** · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2009-04-30
## Drug
- **FDA Application Number:** ANDA077954
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** AZELASTINE HYDROCHLORIDE
- **Generic name:** AZELASTINE HYDROCHLORIDE
- **Active ingredients:** AZELASTINE HYDROCHLORIDE
- **Dosage form:** SPRAY, METERED
- **Route:** NASAL
- **Marketing status:** Prescription
- **Sponsor:** APOTEX INC
- **Manufacturer:** Apotex Corp.
- **First approval:** 2009-04-30
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077954)
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