Assyro AI

Orange Book product · Brand (NDA)

BONDLIDO

LIDOCAINE

Brand (NDA)NDA 215029RX MEDRX USA

At a glance

Sep 24, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 24, 2025

    9 mo ago

  2. Today

  3. Exclusivity ends · NP

    New product exclusivity (3 years)

    Sep 24, 2028

    in 2 yr 4 mo

Pharmaceutical detail

Active ingredient

LIDOCAINE

Strength

10%

Dosage form

SYSTEM

Route

TOPICAL

TE code

Not listed

Application

NDA 215029

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Sep 24, 2028

    in 2 yr 4 mo

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.