Orange Book product · Generic (ANDA)
CLADRIBINE
CLADRIBINE
Generic (ANDA)ANDA 215547TE ABRX HOPEWELL PHARMA
At a glance
Mar 27, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 27, 2026
3 mo ago
Today
Pharmaceutical detail
Active ingredient
CLADRIBINE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215547
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
- 2025CLADRIBINEGeneric (ANDA)
ANDA 218425 · APOTEX
- 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.
