NDC 11797-157
fondaparinux sodium 10 mg per 0.8 mL injection, solution
On the label: Italfarmaco S.p.A.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Italfarmaco SPA | Milan, Italy | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 28, 2023 · 6 inspections |
| ScinoPharm Taiwan, Ltd. | Tainan, Taiwan | Makes the active ingredient | Serious problems, FDA actionJun 23, 2026 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Fondaparinux: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 10 mg per 0.8 mL
- Approval
- ANDA ANDA208615
- On the market since
- Feb 6, 2019
- Package NDCs
11797-157-0211797-157-0611797-157-09- Official label
- DailyMed (National Library of Medicine), updated Oct 30, 2020
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