Drug application

EMTRIVA (EMTRICITABINE)

Drugs@FDA NDA 021500 · GILEAD

Key facts

Drug name EMTRIVA
Active ingredients EMTRICITABINE
Application type NDA
Application number 021500
Company GILEAD
Dosage forms CAPSULE, ORAL
Strength 200MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Jul 2, 2003

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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 · Source date:

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