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CardiovascularORALGeneric

ROSZET

EZETIMIBE; ROSUVASTATIN CALCIUM

Standard Dose
10MG;EQ 5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ROSZET is listed in Drugs@FDA under application 213072 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient EZETIMIBE; ROSUVASTATIN CALCIUM Form and strength TABLET;ORAL - 10MG;EQ 5MG BASE Sponsor ALTHERA PHARMS Submission history Latest submission status date: 2024-08-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROSZET is listed in Drugs@FDA under application 213072 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient EZETIMIBE; ROSUVASTATIN CALCIUM Form and strength TABLET;ORAL - 10MG;EQ 5MG BASE Sponsor ALTHERA PHARMS Submission history Latest submission status date: 2024-08-26 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.