Orange Book product · Generic (ANDA)
FLUDARABINE PHOSPHATE
FLUDARABINE PHOSPHATE
At a glance
Oct 15, 2007
Approved
Generic (ANDA)
Application
AP1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 15, 2007
18 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUDARABINE PHOSPHATE
Strength
50MG/2ML (25MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP1
Application
ANDA 078393
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 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.
