Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr.reddy's Laboratories Limited | Visakhapatnam, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 17, 2024 · 9 inspections, 2 with FDA action |
Product details
- Generic drug
- 4-Hydroxycyclophosphamide: every company that makes it
- Form
- injection, intravenous
- Strength
- 500 mg per 1 mL
- Approval
- NDA NDA210852
- On the market since
- Aug 1, 2024
- Package NDCs
83831-116-01- Official label
- DailyMed (National Library of Medicine), updated Jul 26, 2024
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