Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Justesa Imagen, S.A.U. | Coslada, Spain | Makes the active ingredient | Problems found, fixed voluntarilyMar 10, 2022 · 4 inspections |
| Liebel-Flarsheim Company LLC | Raleigh, NC, United States | Makes it and tests it | Serious problems, FDA actionApr 8, 2025 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Iothalamic Acid: every company that makes it
- Form
- injection, ureteral
- Strength
- 172 mg per 1 mL
- Approval
- NDA NDA017057
- On the market since
- Oct 8, 2010
- Package NDCs
0019-0862-50- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2020
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