Drug application

STRIBILD (COBICISTAT, ELVITEGRAVIR, EMTRICITABINE and 1 more)

Drugs@FDA NDA 203100 · GILEAD SCIENCES INC

Key facts

Drug name STRIBILD
Active ingredients COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE
Application type NDA
Application number 203100
Company GILEAD SCIENCES INC
Dosage forms TABLET, ORAL
Strength 150MG;150MG;200MG;300MG
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity and Type 4 - New Combination
Latest submission status date Aug 27, 2012

At a glance

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