Orange Book product
FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML)
Orange Book ANDA 076661 · SAGENT PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | FLUDARABINE PHOSPHATE |
|---|---|
| Active ingredients | FLUDARABINE PHOSPHATE |
| Strength | 50MG/2ML (25MG/ML) |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA076661 |
| Applicant holder | SAGENT PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP1 |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 28, 2004 |
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.