← FDA Drug Approvals (Drugs@FDA)
FLUOROURACIL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ENCUBE · Approved 2025-02-12
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown