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General MedicationsORALGeneric

VIEKIRA XR

DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

Standard Dose
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview VIEKIRA XR is listed in Drugs@FDA under application 208624 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE Submission history Latest submission status date: 2019-12-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview VIEKIRA XR is listed in Drugs@FDA under application 208624 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE Submission history Latest submission status date: 2019-12-06 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.