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Active ingredient

Nelarabine

16 finished FDA listings contain Nelarabine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
NELARABINE
Dosage forms
Injection, Injection, Solution
Routes
Intravenous
Manufacturers / labelers
14
Strengths listed
5 mg/ml
Brand names in FDA listings
Arranon

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 274771

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021877SANDOZ2005-10-282
ANDA 215037ZYDUS PHARMS2021-11-173
ANDA 216934DR REDDYS2022-12-221
ANDA 216038MEITHEAL2023-01-101
ANDA 214809SHORLA2023-03-032
ANDA 216346AMNEAL2023-04-041
ANDA 212605GLAND2024-01-032
ANDA 218554ALEMBIC2024-08-012
ANDA 216510PHARMOBEDIENT2024-09-051
ANDA 216948MSN2024-09-131

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.