# SPORANOX
> **NDA020083** · New Drug Application · Sponsor: JANSSEN PHARMS · Approved 1992-09-11
## Drug
- **FDA Application Number:** NDA020083
- **Application type:** New Drug Application
- **Brand name:** SPORANOX
- **Generic name:** ITRACONAZOLE
- **Active ingredients:** ITRACONAZOLE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** JANSSEN PHARMS
- **Manufacturer:** Janssen Pharmaceuticals, Inc.
- **First approval:** 1992-09-11
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020083)
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