Drug application

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE)

Drugs@FDA ANDA 203442 · MACLEODS PHARMS

Key facts

Drug name EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Active ingredients EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE
Application type ANDA
Application number 203442
Company MACLEODS PHARMS
Dosage forms TABLET, ORAL
Strength 200MG;300MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 15, 2020

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

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

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