Is Arranon still available?

Yes. Arranon (NDA 021877) is listed with marketing status Prescription in the FDA Orange Book.

Does Arranon have a generic?

Yes. The Orange Book lists 10 approved generic (ANDA) applications sharing Arranon's active ingredient (Nelarabine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Arranon's TE code AP mean?

AP is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Arranon substitutable for its reference brand with no expected difference in clinical effect.

What is Arranon's FDA application number?

Arranon is approved under NDA 021877, held by Sandoz.

Orange Book product · Brand (NDA)

Arranon

Nelarabine

Brand (NDA)NDA 021877TE APRLD Sandoz

Approved

Oct 28, 2005

Application

Brand (NDA)

TE code

Listed patents

Arranon (Nelarabine) is Sandoz's brand-name drug, approved by the FDA under NDA 021877 in 2005. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AP, so the FDA considers it substitutable for the reference brand. 10 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 28, 2005
21 yr ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

NELARABINE

Strength

250MG/50ML (5MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 021877

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Nelarabine family

Orange Book patent file

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.

Arranon — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Nelarabine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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