# ELMIRON
> **NDA020193** · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 1996-09-26
## Drug
- **FDA Application Number:** NDA020193
- **Application type:** New Drug Application
- **Brand name:** ELMIRON
- **Generic name:** PENTOSAN POLYSULFATE SODIUM
- **Active ingredients:** PENTOSAN POLYSULFATE SODIUM
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** JANSSEN PHARMS
- **Manufacturer:** Janssen Pharmaceuticals, Inc.
- **First approval:** 1996-09-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020193)
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