Drug application

AGENERASE (AMPRENAVIR)

Drugs@FDA NDA 021007 · GLAXOSMITHKLINE

Key facts

Drug name AGENERASE
Active ingredients AMPRENAVIR
Application type NDA
Application number 021007
Company GLAXOSMITHKLINE
Dosage forms CAPSULE, ORAL
Strength 50MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Apr 15, 1999

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 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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