NDC 65219-564
Mitomycin 5 mg per 10 mL injection, powder, lyophilized, for solution
On the label: Fresenius Kabi USA, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gland Pharma Limited | Visakhapatnam, India | Makes it, tests it and packages it | No problems foundJul 28, 2023 · 8 inspections |
Product details
- Generic drug
- Mitomycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 5 mg per 10 mL
- Approval
- ANDA ANDA215687
- On the market since
- Jan 15, 2023
- Package NDCs
65219-564-20- Official label
- DailyMed (National Library of Medicine), updated Jan 9, 2023
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