Orange Book product · Brand (NDA)
ARRANON
NELARABINE
At a glance
Oct 28, 2005
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 28, 2005
20 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
NELARABINE
Strength
250MG/50ML (5MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
NDA 021877
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024NELARABINEGeneric (ANDA)
ANDA 216948 · MSN
- 2024NELARABINEGeneric (ANDA)
ANDA 216510 · XGEN PHARMS
- 2024NELARABINEGeneric (ANDA)
ANDA 218554 · ALEMBIC
- 2024NELARABINEGeneric (ANDA)
ANDA 212605 · GLAND
- 2023NELARABINEGeneric (ANDA)
ANDA 215057 · NEXUS
- 2023NELARABINEGeneric (ANDA)
ANDA 216346 · AMNEAL
- 2023NELARABINEGeneric (ANDA)
ANDA 214809 · SHORLA
- 2023NELARABINEGeneric (ANDA)
ANDA 216038 · MEITHEAL
- 2022NELARABINEGeneric (ANDA)
ANDA 216934 · DR REDDYS
- 2021NELARABINEGeneric (ANDA)
ANDA 215037 · ZYDUS PHARMS
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.
