Orange Book product · Generic (ANDA)
CLADRIBINE
CLADRIBINE
At a glance
Nov 24, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 24, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
CLADRIBINE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 218425
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLADRIBINE
- 2019MAVENCLADBrand (NDA)
NDA 022561 · EMD SERONO INC
- 1993LEUSTATINBrand (NDA)
NDA 020229 · JANSSEN PHARMS
- 2026CLADRIBINEGeneric (ANDA)
ANDA 215547 · HOPEWELL PHARMA
- 2019CLADRIBINEGeneric (ANDA)
ANDA 210856 · HISUN PHARM HANGZHOU
- 2011CLADRIBINEGeneric (ANDA)
ANDA 200510 · PHARMOBEDIENT
- 2004CLADRIBINEGeneric (ANDA)
ANDA 076571 · FRESENIUS KABI USA
- 2000CLADRIBINEGeneric (ANDA)
ANDA 075405 · 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.
