Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Janssen Ortho LLC | Gurabo, PR, United States | Makes it and tests it | Problems found, fixed voluntarilyMar 28, 2023 · 7 inspections |
| bene pharmaChem GmbH & Co. KG | Geretsried, Germany | Makes the active ingredient | Problems found, fixed voluntarilyNov 8, 2018 · 4 inspections |
Product details
- Generic drug
- Pentosan Polysulfate: every company that makes it
- Form
- capsule, gelatin coated, oral
- Strength
- 100 mg
- Approval
- NDA NDA020193
- On the market since
- Sep 26, 1996
- Package NDCs
50458-098-01- Official label
- DailyMed (National Library of Medicine), updated Sep 18, 2024
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