Orange Book product
FLUDARABINE PHOSPHATE 50MG/VIAL
Orange Book ANDA 078610 · ACTAVIS TOTOWA LLC · Prescription
Key facts
| Proprietary name | FLUDARABINE PHOSPHATE |
|---|---|
| Active ingredients | FLUDARABINE PHOSPHATE |
| Strength | 50MG/VIAL |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA078610 |
| Applicant holder | ACTAVIS TOTOWA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Feb 11, 2009 |
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.