Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Liebel-Flarsheim Company LLC | Raleigh, NC, United States | Makes it, packages it and labels it | Serious problems, FDA actionApr 8, 2025 · 7 inspections, 1 with FDA action |
| PCAS Finland Oy | Turku, Finland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 10, 2024 · 7 inspections |
| Simafex | Marans, France | Makes the active ingredient | Problems found, fixed voluntarilyJan 31, 2025 · 5 inspections |
Product details
- Generic drug
- Gadolinium Cation (3+): every company that makes it
- Form
- injection, intravenous
- Strength
- 376.9 mg per 1 mL
- Approval
- NDA NDA204781
- On the market since
- Sep 18, 2019
- Package NDCs
67684-3001-167684-3001-267684-3001-3- Official label
- DailyMed (National Library of Medicine), updated Mar 14, 2025
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