# EFUDEX
> **NDA016831** · New Drug Application · Sponsor: EXTROVIS · Approved 1970-07-29
## Drug
- **FDA Application Number:** NDA016831
- **Application type:** New Drug Application
- **Brand name:** EFUDEX
- **Generic name:** FLUOROURACIL
- **Active ingredients:** FLUOROURACIL
- **Dosage form:** CREAM
- **Route:** TOPICAL
- **Marketing status:** Prescription
- **Sponsor:** EXTROVIS
- **Manufacturer:** Mylan Pharmaceuticals Inc.
- **First approval:** 1970-07-29
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=016831)
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