Assyro AI

Orange Book product · Brand (NDA)

SYNERA

LIDOCAINE; TETRACAINE

Brand (NDA)NDA 021623DISCN GALEN SPECIALTY

At a glance

Jun 23, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 23, 2005

    21 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LIDOCAINE; TETRACAINE

Strength

70MG;70MG

Dosage form

PATCH

Route

TOPICAL

TE code

Not listed

Application

NDA 021623

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

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.