NDC 47335-938
Azelastine Hydrochloride 0.5 mg per 1 mL solution/ drops
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Product details
- Generic drug
- Azelastine: every company that makes it
- Form
- solution/ drops, intraocular
- Strength
- 0.5 mg per 1 mL
- Approval
- ANDA ANDA078738
- On the market since
- May 31, 2010
- Package NDCs
47335-938-90- Official label
- DailyMed (National Library of Medicine), updated Oct 24, 2018
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