Drug application

VIEKIRA PAK (COPACKAGED) (DASABUVIR SODIUM, OMBITASVIR, PARITAPREVIR, RITONAVIR)

Drugs@FDA NDA 206619 · ABBVIE

Key facts

Drug name VIEKIRA PAK (COPACKAGED)
Active ingredients DASABUVIR SODIUM, OMBITASVIR, PARITAPREVIR, RITONAVIR
Application type NDA
Application number 206619
Company ABBVIE
Dosage forms TABLET, ORAL
Strength EQ 250MG BASE;12.5MG, 75MG, 50MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity and Type 4 - New Combination
Latest submission status date Dec 19, 2014

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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