Assyro AI

Orange Book product · Generic (ANDA)

LACOSAMIDE

LACOSAMIDE

Generic (ANDA)ANDA 216461TE AARX KANCHAN HLTHCARE

At a glance

Feb 06, 2023

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 06, 2023

    3 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LACOSAMIDE

Strength

10MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 216461

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LACOSAMIDE

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.