Orange Book product

LAMOTRIGINE 200MG

Orange Book ANDA 078134 · HIKMA PHARMACEUTICALS · Discontinued

Key facts

Proprietary name LAMOTRIGINE
Active ingredients LAMOTRIGINE
Strength 200MG
Dosage form TABLET
Route ORAL
Application ANDA078134
Applicant holder HIKMA PHARMACEUTICALS
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 19, 2011

At a glance

  • 10–99 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No 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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