FLUOROURACIL (FLUOROURACIL CREAM, 0.5%)
Summary
FDA approved FLUOROURACIL (FLUOROURACIL CREAM, 0.5%) by EXTROVIS. NDA (New Drug) approval (Manufacturing (CMC)) on 2025-07-01. CREAM, TOPICAL.
Details
Source
Drug Approval
External ID
NDA020985-21
Action Date
2025-07-01
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
FLUOROURACIL (generic: FLUOROURACIL CREAM, 0.5%), CREAM, TOPICAL. Application: NDA020985
Company
Context & Analysis
EXTROVIS has 3 FDA actions in our database.
Frequently Asked Questions
How often does EXTROVIS have FDA actions?
EXTROVIS has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA020985-21" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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