Orange Book product

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG

Orange Book ANDA 090958 · CIPLA LTD · Discontinued

Key facts

Proprietary name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Active ingredients EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE
Strength 200MG;300MG
Dosage form TABLET
Route ORAL
Application ANDA090958
Applicant holder CIPLA LTD
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 2, 2021

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)

Browse all Orange Book products