Orange Book product · Generic (ANDA)
NELARABINE
NELARABINE
At a glance
Nov 17, 2021
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 17, 2021
4 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
NELARABINE
Strength
250MG/50ML (5MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 215037
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
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ANDA 216948 · MSN
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ANDA 216510 · XGEN PHARMS
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ANDA 218554 · ALEMBIC
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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
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.
