Orange Book product
FLUOROURACIL 500MG/10ML (50MG/ML)
Orange Book ANDA 202668 · EUGIA PHARMA SPECIALITIES LTD · Prescription
Key facts
| Proprietary name | FLUOROURACIL |
|---|---|
| Active ingredients | FLUOROURACIL |
| Strength | 500MG/10ML (50MG/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA202668 |
| Applicant holder | EUGIA PHARMA SPECIALITIES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 17, 2012 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No 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.