Orange Book product · Generic (ANDA)
CLADRIBINE
CLADRIBINE
At a glance
Feb 28, 2000
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2000
26 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CLADRIBINE
Strength
1MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 075405
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
- 2025CLADRIBINEGeneric (ANDA)
ANDA 218425 · APOTEX
- 2019CLADRIBINEGeneric (ANDA)
ANDA 210856 · HISUN PHARM HANGZHOU
- 2011CLADRIBINEGeneric (ANDA)
ANDA 200510 · PHARMOBEDIENT
- 2004CLADRIBINEGeneric (ANDA)
ANDA 076571 · FRESENIUS KABI USA
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.
