FDA Orange Book

Generic for Arranon

Arranon contains nelarabine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Arranon is nelarabine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Arranon products in the Orange Book

Arranon products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, intravenous250MG/50ML (5MG/ML)Marketed (Rx)AP10AP

NDA 021877, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic nelarabine

Approved generic versions of Arranon
CompanyANDATE codeApprovedStrengths
ZYDUS PHARMACEUTICALS USA INC215037AP (A-rated, therapeutically equivalent)November 17, 2021250MG/50ML (5MG/ML)
DR REDDYS LABORATORIES LTD216934AP (A-rated, therapeutically equivalent)December 23, 2022250MG/50ML (5MG/ML)
MEITHEAL PHARMACEUTICALS INC216038AP (A-rated, therapeutically equivalent)January 10, 2023250MG/50ML (5MG/ML)
SHORLA PHARMA LTD214809AP (A-rated, therapeutically equivalent)March 3, 2023250MG/50ML (5MG/ML)
AMNEAL EU LTD216346AP (A-rated, therapeutically equivalent)April 4, 2023250MG/50ML (5MG/ML)
NEXUS PHARMACEUTICALS LLC215057AP (A-rated, therapeutically equivalent)June 2, 2023250MG/50ML (5MG/ML)
GLAND PHARMA LTD212605AP (A-rated, therapeutically equivalent)January 3, 2024250MG/50ML (5MG/ML)
ALEMBIC PHARMACEUTICALS LTD218554AP (A-rated, therapeutically equivalent)August 1, 2024250MG/50ML (5MG/ML)
PHARMOBEDIENT CONSULTING LLC216510AP (A-rated, therapeutically equivalent)September 5, 2024250MG/50ML (5MG/ML)
MSN LABORATORIES PRIVATE LTD216948AP (A-rated, therapeutically equivalent)September 13, 2024250MG/50ML (5MG/ML)

Arranon NDC codes

Questions

Is there a generic for Arranon?

Yes. The generic name for Arranon is nelarabine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Arranon?

The active ingredient in Arranon is nelarabine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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