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CardiovascularORALStandard

SIMVASTATIN

SIMVASTATIN

Standard Dose
80MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SIMVASTATIN is listed in Drugs@FDA under application 211394 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SIMVASTATIN Form and strength TABLET;ORAL - 80MG Sponsor YILING Submission history Latest submission status date: 2024-11-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview SIMVASTATIN is listed in Drugs@FDA under application 211394 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SIMVASTATIN Form and strength TABLET;ORAL - 80MG Sponsor YILING Submission history Latest submission status date: 2024-11-27 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.