Orange Book product · Generic (ANDA)
FLUDARABINE PHOSPHATE
FLUDARABINE PHOSPHATE
At a glance
Apr 28, 2004
Approved
Generic (ANDA)
Application
AP1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2004
22 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUDARABINE PHOSPHATE
Strength
50MG/2ML (25MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP1
Application
ANDA 076661
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUDARABINE PHOSPHATE
- 2008OFORTABrand (NDA)
NDA 022273 · SANOFI AVENTIS US
- 2007FLUDARABINE PHOSPHATEBrand (NDA)
NDA 022137 · CAPLIN ONE LABS
- 1991FLUDARABrand (NDA)
NDA 020038 · GENZYME CORP
- 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
- 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.
