Orange Book product
EFUDEX 5% **Federal Register determination that product was not…
Orange Book NDA 016831 · EXTROVIS AG · Discontinued
Key facts
| Proprietary name | EFUDEX |
|---|---|
| Active ingredients | FLUOROURACIL |
| Strength | 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | SOLUTION |
| Route | TOPICAL |
| Application | NDA016831 |
| Applicant holder | EXTROVIS AG |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jan 1, 1982 |
At a glance
- None Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.