Assyro AI

Orange Book product · Generic (ANDA)

LAMOTRIGINE

LAMOTRIGINE

Generic (ANDA)ANDA 090170TE ABRX UNICHEM LABS LTD

At a glance

Oct 06, 2011

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 06, 2011

    14 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LAMOTRIGINE

Strength

25MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 090170

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LAMOTRIGINE

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.