Orange Book product · Generic (ANDA)
NELARABINE
NELARABINE
At a glance
Sep 13, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 13, 2024
1 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NELARABINE
Strength
250MG/50ML (5MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 216948
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NELARABINE
- 2005ARRANONBrand (NDA)
NDA 021877 · SANDOZ
- 2024NELARABINEGeneric (ANDA)
ANDA 216510 · XGEN PHARMS
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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.
