Is Banzel still available?

Yes. Banzel (NDA 021911) is listed with marketing status Prescription in the FDA Orange Book.

Does Banzel have a generic?

Yes. The Orange Book lists 15 approved generic (ANDA) applications sharing Banzel's active ingredient (Rufinamide). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Banzel's TE code AB mean?

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

What is Banzel's FDA application number?

Banzel is approved under NDA 021911, held by Eisai Inc.

Orange Book product · Brand (NDA)

Banzel

Rufinamide

Brand (NDA)NDA 021911TE ABRLD Eisai Inc

Approved

Nov 14, 2008

Application

Brand (NDA)

TE code

Listed patents

Banzel (Rufinamide) is Eisai Inc's brand-name drug, approved by the FDA under NDA 021911 in 2008. 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 AB, so the FDA considers it substitutable for the reference brand. 15 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.
Nov 14, 2008
17 yr 11 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

RUFINAMIDE

Strength

400MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021911

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 021911

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 Rufinamide 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.

Banzel — 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 Rufinamide active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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