NDC 69448-003
Mutamycin 40 mg per 80 mL injection, powder, lyophilized, for solution
On the label: Accord BioPharma Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Mitomycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 40 mg per 80 mL
- Approval
- ANDA ANDA064144
- On the market since
- Jul 25, 2017
- Package NDCs
69448-003-38- Official label
- DailyMed (National Library of Medicine), updated Mar 12, 2025
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