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CardiovascularORALStandard

FLOLIPID

SIMVASTATIN

Standard Dose
40MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Prescription
Summary

Approval overview FLOLIPID is listed in Drugs@FDA under application 206679 (NDA).

Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient SIMVASTATIN Form and strength SUSPENSION;ORAL - 40MG/5ML Sponsor SALERNO PHARMS Submission history Latest submission status date: 2020-09-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLOLIPID is listed in Drugs@FDA under application 206679 (NDA). Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient SIMVASTATIN Form and strength SUSPENSION;ORAL - 40MG/5ML Sponsor SALERNO PHARMS Submission history Latest submission status date: 2020-09-25 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.