Drug application

DARUNAVIR (DARUNAVIR)

Drugs@FDA ANDA 211578 · DR REDDYS

Key facts

Drug name DARUNAVIR
Active ingredients DARUNAVIR
Application type ANDA
Application number 211578
Company DR REDDYS
Dosage forms TABLET, ORAL
Strength 600MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Nov 28, 2023

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • No 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:

Browse all Drugs@FDA applications