Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira Australia Pty Ltd | Mulgrave, Australia | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilySep 2, 2022 · 6 inspections, 1 with FDA action |
| Zydus Hospira Oncology Private Limited | Ahmedabad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 30, 2023 · 5 inspections |
Product details
- Generic drug
- Topotecan: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 1 mg per 1 mL
- Approval
- NDA NDA200582
- On the market since
- Feb 21, 2011
- Package NDCs
0409-0302-01- Official label
- DailyMed (National Library of Medicine), updated Feb 1, 2021
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