Orange Book product · Brand (NDA)
LEUSTATIN
CLADRIBINE
At a glance
Feb 26, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 26, 1993
33 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CLADRIBINE
Strength
1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020229
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019MAVENCLADBrand (NDA)
NDA 022561 · EMD SERONO INC
- 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
- 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.
