Orange Book product

LAMICTAL 150MG

Orange Book NDA 020241 · GLAXOSMITHKLINE LLC · Prescription

Key facts

Proprietary name LAMICTAL
Active ingredients LAMOTRIGINE
Strength 150MG
Dosage form TABLET
Route ORAL
Application NDA020241
Applicant holder GLAXOSMITHKLINE LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Dec 27, 1994

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

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

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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