Drug application

LAMOTRIGINE (LAMOTRIGINE)

Drugs@FDA ANDA 078443 · PHARMOBEDIENT

Key facts

Drug name LAMOTRIGINE
Active ingredients LAMOTRIGINE
Application type ANDA
Application number 078443
Company PHARMOBEDIENT
Dosage forms TABLET, ORAL
Strength 25MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Feb 11, 2009

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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