# AZELASTINE HYDROCHLORIDE
> **ANDA209620** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2019-03-20
## Drug
- **FDA Application Number:** ANDA209620
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** AZELASTINE HYDROCHLORIDE
- **Generic name:** AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05%
- **Active ingredients:** AZELASTINE HYDROCHLORIDE
- **Dosage form:** SOLUTION/DROPS
- **Route:** OPHTHALMIC
- **Marketing status:** Prescription
- **Sponsor:** ALEMBIC
- **Manufacturer:** Alembic Pharmaceuticals Inc.
- **First approval:** 2019-03-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209620)
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