# FLUOROURACIL
> **ANDA216942** · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE · Approved 2025-02-12
## Drug
- **FDA Application Number:** ANDA216942
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** FLUOROURACIL
- **Generic name:** FLUOROURACIL
- **Active ingredients:** FLUOROURACIL
- **Dosage form:** CREAM
- **Route:** TOPICAL
- **Marketing status:** Prescription
- **Sponsor:** ENCUBE
- **Manufacturer:** Encube Ethicals, Inc.
- **First approval:** 2025-02-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216942)
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