Orange Book product

LAMIVUDINE 300MG

Orange Book ANDA 090198 · MACLEODS PHARMACEUTICALS LTD · Prescription

Key facts

Proprietary name LAMIVUDINE
Active ingredients LAMIVUDINE
Strength 300MG
Dosage form TABLET
Route ORAL
Application ANDA090198
Applicant holder MACLEODS PHARMACEUTICALS LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 1, 2019

At a glance

  • 1–9 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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