Orange Book product · Brand (NDA)
FLUDARA
FLUDARABINE PHOSPHATE
At a glance
Apr 18, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 18, 1991
35 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUDARABINE PHOSPHATE
Strength
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020038
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2008OFORTABrand (NDA)
NDA 022273 · SANOFI AVENTIS US
- 2007FLUDARABINE PHOSPHATEBrand (NDA)
NDA 022137 · CAPLIN ONE LABS
- 2017FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 203738 · ACTAVIS LLC
- 2012FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 200648 · RISING
- 2011FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 200647 · EXTROVIS
- 2010FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 090724 · AREVA PHARMS
- 2009FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 078610 · ACTAVIS TOTOWA
- 2007FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 078393 · FRESENIUS KABI USA
- 2007FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 078544 · FRESENIUS KABI USA
- 2007FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 077790 · HOSPIRA
- 2004FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 076661 · SAGENT PHARMS INC
- 2003FLUDARABINE PHOSPHATEGeneric (ANDA)
ANDA 076349 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
