Drug application

DARUNAVIR AND RITONAVIR (DARUNAVIR AND RITONAVIR)

Drugs@FDA NDA 209847 · MYLAN PHARMS INC

Key facts

Drug name DARUNAVIR AND RITONAVIR
Active ingredients DARUNAVIR AND RITONAVIR
Application type NDA
Application number 209847
Company MYLAN PHARMS INC
Dosage forms TABLET, ORAL
Strength 400MG/50MG
Marketing status Prescription
Reference listed drug No
Latest submission class Type 4 - New Combination
Latest submission status date Dec 22, 2023

At a glance

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

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