Drug application

DARUNAVIR (DARUNAVIR)

Drugs@FDA ANDA 202083 · HETERO LABS LTD III

Key facts

Drug name DARUNAVIR
Active ingredients DARUNAVIR
Application type ANDA
Application number 202083
Company HETERO LABS LTD III
Dosage forms TABLET, ORAL
Strength 400MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Sep 14, 2023

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 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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